Cook, Inc.: FDA filings under this applicant name
FDA lists 190 510(k) clearances under the applicant name “Cook, Inc.” (first 1976, latest 2015), plus 5 PMA decisions, across 68 product codes in 10 review panels. Median 510(k) review time under this name: 91 days. 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 | 2 | 55 |
| 2013 | 12 | 118 |
| 2014 | 5 | 275 |
| 2015 | 1 | 466 |
| 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 20 | 20 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 20 | 20 |
| DQX | Wire, Guide, Catheter | 12 | 12 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 12 | 12 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 11 | 11 |
| KRA | Catheter, Continuous Flush | 8 | 8 |
| KRD | Device, Vascular, For Promoting Embolization | 7 | 7 |
| JAK | System, X-Ray, Tomography, Computed | 6 | 6 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 5 | 5 |
Plus 58 more product codes.
Review panels
- Cardiovascular (85)
- Gastroenterology and Urology (33)
- General Hospital (22)
- Anesthesiology (17)
- Radiology (15)
- Neurology (8)
- General and Plastic Surgery (7)
- Obstetrics and Gynecology (5)
- Ear, Nose and Throat (1)
- Orthopedic (1)
Most recent Cook, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | DQO | 2015-01-09 | 466 |
| K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | GCJ | 2014-12-15 | 283 |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | DYB | 2014-10-09 | 416 |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | JOH | 2014-04-18 | 147 |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | KRA | 2014-02-20 | 248 |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | DQY | 2014-01-29 | 275 |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | LJS | 2013-12-23 | 27 |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | LIT | 2013-10-25 | 116 |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | FGE | 2013-10-07 | 161 |
| K131206 | COOK CERVICAL RIPENING BALLOON | PFJ | 2013-09-27 | 151 |
180 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020018 | PMA | ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM | 2003-05-23 |
| P990008 | PMA | COOK MBC PTCA BALLOON DILATATION CATHETER | 1999-09-27 |
| P910030 | PMA | GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) | 1993-02-08 |
| P880078 | PMA | VH8500 HYPERTHERMIA TREATMENT SYSTEM | 1989-10-17 |
| P850049 | PMA | COOK BIRD'S NEST VENA CAVA FILTER | 1989-04-26 |
Recalls
564 product recalls in 78 recall events; 5 initiated in the last five years. Most recent: 2021-11-12.
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 Cook, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
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 Incorporated (174 510(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, Inc.?
FDA lists 190 510(k) clearances under the applicant name “Cook, Inc.” (first 1976, latest 2015), plus 5 PMA decisions, across 68 product codes in 10 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook, Inc. is 91 days.
Which FDA product codes appear under Cook, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 20); FGE (Stents, Drains And Dilators For The Biliary Ducts, 20); DQX (Wire, Guide, Catheter, 12).
Next steps
- See all 190 Cook, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Cook, Inc.'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.