Covidien: FDA filings under this applicant name
FDA lists 224 510(k) clearances under the applicant name “Covidien” (first 2008, latest 2026), plus 2 PMA and 1 De Novo decisions, across 63 product codes in 9 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 125 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 13 | 50 |
| 2013 | 14 | 84 |
| 2014 | 24 | 60 |
| 2015 | 33 | 146 |
| 2016 | 26 | 82 |
| 2017 | 11 | 59 |
| 2018 | 17 | 111 |
| 2019 | 7 | 125 |
| 2020 | 16 | 98 |
| 2021 | 7 | 143 |
| 2022 | 13 | 162 |
| 2023 | 9 | 119 |
| 2024 | 6 | 208 |
| 2025 | 5 | 268 |
| 2026 | 5 | 174 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Covidien took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 41 | 41 |
| GDW | Staple, Implantable | 27 | 27 |
| GCJ | Laparoscope, General & Plastic Surgery | 13 | 13 |
| DQA | Oximeter | 10 | 10 |
| JOW | Sleeve, Limb, Compressible | 8 | 8 |
| JOH | Tube Tracheostomy And Tube Cuff | 7 | 7 |
| BTR | Tube, Tracheal (W/Wo Connector) | 6 | 6 |
| GAG | Stapler, Surgical | 5 | 5 |
| NEY | System, Ablation, Microwave And Accessories | 5 | 5 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
Plus 53 more product codes.
Review panels
- General and Plastic Surgery (115)
- Anesthesiology (35)
- Gastroenterology and Urology (27)
- Cardiovascular (18)
- General Hospital (11)
- Ear, Nose and Throat (7)
- Neurology (6)
- Radiology (6)
- Obstetrics and Gynecology (2)
Most recent Covidien 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | GEI | 2026-09-15 | 167 |
| K260907 | BIS Advance pEEG Module | OLW | 2026-08-13 | 147 |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | GAG | 2026-07-01 | 230 |
| K253984 | Instrument Exit Point on Touch Surgery Aide | SFE | 2026-06-04 | 174 |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | CCK | 2026-05-01 | 224 |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | JOH | 2025-12-29 | 245 |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | 2025-12-29 | 271 |
| K250725 | Hugo RAS System | SCV | 2025-12-03 | 268 |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | BTR | 2025-10-06 | 258 |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | 2025-09-25 | 290 |
214 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220006 | De Novo | Endoscopic Traction Device | 2022-06-13 |
| P990053 | PMA | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM | 2000-05-12 |
| P890034 | PMA | MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR | 1991-12-13 |
Recalls
569 product recalls in 142 recall events; 134 initiated in the last five years. Most recent: 2026-06-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Covidien (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Covidien, Formerly US Surgical A Divison of Tyco H (13 510(k)s)
- Covidien Lp, Formerly Registered AS United States (7 510(k)s)
- Covidien, Formerly Valleylab, A Division of Tyco H (6 510(k)s)
- Covidien, Formerly Nellcor Puritan Bennett, Inc. (5 510(k)s)
- Covidien Lp, Formerly Registered AS Tyco Healthcar (4 510(k)s)
- Covidien Lp, Formerly Registered AS Kendall (3 510(k)s)
- Covidien, LLC( Formerly Beacon Endoscopic Corp.) (2 510(k)s)
- Covidien, LLC, Formerly Registered AS Tyco Healthca (2 510(k)s)
- Covidien Lp, Formerly Know AS Valleylab, A Divison (2 510(k)s)
- Covidien (Part of Medtronic) (2 510(k)s)
- Covidien (Dba Medtronic) (1 510(k)s)
- Covidien, Formerly Valleylab, (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Covidien?
FDA lists 224 510(k) clearances under the applicant name “Covidien” (first 2008, latest 2026), plus 2 PMA and 1 De Novo decisions, across 63 product codes in 9 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Covidien?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covidien is 106 days. Since 2017: 125 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Covidien?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 41); GDW (Staple, Implantable, 27); GCJ (Laparoscope, General & Plastic Surgery, 13).
Next steps
- See all 224 Covidien clearances with predicates and recalls
- Run predicate analysis for product code GEI, Covidien's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.