Tyco Healthcare: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Tyco Healthcare” (first 2001, latest 2007), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 108 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 1 | 1 |
| NGT | Saline, Vascular Access Flush | 1 | 1 |
Review panels
- General Hospital (5)
- Gastroenterology and Urology (4)
- General and Plastic Surgery (3)
- Cardiovascular (1)
- Hematology (1)
Most recent Tyco Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | EZL | 2007-10-16 | 186 |
| K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | FRO | 2007-09-14 | 186 |
| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | FRO | 2007-09-12 | 187 |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | FMF | 2006-08-03 | 64 |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | EZL | 2005-01-18 | 110 |
| K040897 | DOVER ROB-NEL CATHETER | KOD | 2004-07-20 | 105 |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | JOW | 2004-07-15 | 126 |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | KOD | 2004-07-07 | 57 |
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE | NGT | 2004-06-30 | 328 |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | FRO | 2004-04-29 | 182 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tyco Healthcare.
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.
- Tyco Healthcare Group LP (6 510(k)s)
- Tyco Healthcare/Kendall (4 510(k)s)
- Tyco Healthcare Nancy (2 510(k)s)
- Tyco Electronics Corporation (1 510(k)s)
- Tyco Healthcare Deutschaland GmbH (1 510(k)s)
- Tyco Intl. (Us), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tyco Healthcare?
FDA lists 14 510(k) clearances under the applicant name “Tyco Healthcare” (first 2001, latest 2007), across 9 product codes in 5 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 Tyco Healthcare?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tyco Healthcare is 108 days.
Which FDA product codes appear under Tyco Healthcare?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); EZL (Catheter, Retention Type, Balloon, 2); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 14 Tyco Healthcare clearances with predicates and recalls
- Run predicate analysis for product code FRO, Tyco Healthcare'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.