Cook Incorporated: FDA filings under this applicant name
FDA lists 174 510(k) clearances under the applicant name “Cook Incorporated” (first 2006, latest 2024), plus 1 PMA and 1 De Novo decisions, across 59 product codes in 8 review panels. Median 510(k) review time under this name: 225 days. Since 2017 the median was 236 days, against 115 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 141 |
| 2013 | 4 | 76 |
| 2014 | 3 | 276 |
| 2015 | 13 | 252 |
| 2016 | 18 | 149 |
| 2017 | 40 | 166 |
| 2018 | 58 | 247 |
| 2019 | 24 | 262 |
| 2020 | 1 | 238 |
| 2021 | 2 | 44 |
| 2022 | 1 | 28 |
| 2023 | 1 | 293 |
| 2024 | 1 | 162 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cook Incorporated took a median 236 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 17 | 17 |
| DQX | Wire, Guide, Catheter | 14 | 14 |
| FAD | Stent, Ureteral | 13 | 13 |
| DQO | Catheter, Intravascular, Diagnostic | 10 | 10 |
| LJE | Catheter, Nephrostomy | 8 | 8 |
| MQF | Catheter, Assisted Reproduction | 7 | 7 |
| KRA | Catheter, Continuous Flush | 6 | 6 |
| KRD | Device, Vascular, For Promoting Embolization | 6 | 6 |
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| LKF | Cannula, Manipulator/Injector, Uterine | 5 | 5 |
Plus 49 more product codes.
Review panels
- Cardiovascular (69)
- Gastroenterology and Urology (59)
- Obstetrics and Gynecology (21)
- Anesthesiology (9)
- General Hospital (8)
- General and Plastic Surgery (8)
- Neurology (1)
- Radiology (1)
Most recent Cook Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233177 | Nest VT Vitrification Device | MQK | 2024-03-08 | 162 |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | MMX | 2023-05-16 | 293 |
| K223098 | Bakri Essential Postpartum Balloon | OQY | 2022-10-28 | 28 |
| K210734 | Endovascular Dilator and Sets | DRE | 2021-04-06 | 26 |
| K203670 | Extra Large Check-Flo Introducer | DYB | 2021-02-16 | 62 |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | LJE | 2020-01-29 | 238 |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | LJE | 2019-12-16 | 252 |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | JOH | 2019-12-12 | 30 |
| K191163 | Lumax Guiding Catheter | DQY | 2019-12-12 | 225 |
| K190084 | McLean-Ring Enteral Feeding Tube Set | KNT | 2019-10-11 | 267 |
164 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170055 | De Novo | Retrograde Intubation Set | 2018-12-12 |
| P900007 | PMA | COOK CHORIONIC VILLUS SAMPLING SET | 1994-09-30 |
Recalls
85 product recalls in 16 recall events; 85 initiated in the last five years. Most recent: 2026-04-02.
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.
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.
- Cook, Inc. (190 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Ireland, Ltd. (33 510(k)s)
- Cook Biotech, Inc. (31 510(k)s)
- Cook Biotech Incorporated (16 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Incorporated?
FDA lists 174 510(k) clearances under the applicant name “Cook Incorporated” (first 2006, latest 2024), plus 1 PMA and 1 De Novo decisions, across 59 product codes in 8 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 Cook Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Incorporated is 225 days. Since 2017: 236 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cook Incorporated?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 17); DQX (Wire, Guide, Catheter, 14); FAD (Stent, Ureteral, 13).
Next steps
- See all 174 Cook Incorporated clearances with predicates and recalls
- Run predicate analysis for product code DYB, Cook Incorporated'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.