Medical device manufacturer
Cook Incorporated
Cook Incorporated holds 364 FDA 510(k) clearances across 92 product codes. Median elapsed review time is 142 days. openFDA lists 649 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 364
- Product codes
- 92
- Median review
- 142 days
- Recall records
- 649
How does FDA spell Cook Incorporated?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| COOK INCORPORATED | device/registrationlisting | normalised |
| COOK, INC. | device/registrationlisting | normalised |
| Cook Inc. | device/recall | normalised |
| Cook Inc. | device/enforcement | normalised |
| Cook Incorporated | device/registrationlisting | normalised |
| Cook Incorporated | device/enforcement | normalised |
| Cook Incorporated | device/recall | normalised |
| Cook Incorporated | device/510k | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Cook Incorporated file in?
92 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | 26 | 89 days | |
| DQY | Catheter, Percutaneous | 22 | 37 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 22 | 70 days | |
| DYB | Introducer, Catheter | 20 | 210 days | |
| DQO | Catheter, Intravascular, Diagnostic | 15 | 261 days | |
| KRA | Catheter, Continuous Flush | 14 | 82 days | |
| FAD | Stent, Ureteral | 13 | 266 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 13 | 218 days | |
| KRD | Device, Vascular, For Promoting Embolization | 13 | 140 days | |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 | 116 days | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 9 | 87 days | |
| LJE | Catheter, Nephrostomy | 8 | 238 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 7 | 191 days | |
| MQF | Catheter, Assisted Reproduction | 7 | 188 days | |
| BWC | Needle, Emergency Airway | 6 | 146 days | |
| DTK | Filter, Intravascular, Cardiovascular | 6 | 86 days | |
| GEX | Powered Laser Surgical Instrument | 6 | 90 days | |
| JAK | System, X-Ray, Tomography, Computed | 6 | 90 days | |
| JOH | Tube Tracheostomy And Tube Cuff | 6 | 63 days | |
| LQR | Dislodger, Stone, Biliary | 6 | 69 days | |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 5 | 152 days | |
| KOD | Catheter, Urological | 5 | 241 days | |
| LKF | Cannula, Manipulator/Injector, Uterine | 5 | 266 days | |
| EZN | Dilator, Catheter, Ureteral | 4 | 119 days | |
| MMX | Device, Percutaneous Retrieval | 4 | 127 days |
Showing the 25 they file in most, of 92.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Cook Incorporated had a recall?
openFDA lists 649 recall records naming this company across its whole history, of which 24 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1934-2026Class IOpen, ClassifiedDQO
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1935-2026Class IOpen, ClassifiedDQO
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1936-2026Class IOpen, ClassifiedDQO
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1775-2026Class IIOpen, ClassifiedDQX
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1776-2026Class IIOpen, ClassifiedDQX
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Showing the 5 most recently initiated of 649.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Cook Incorporated cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K233177 | Nest VT Vitrification Device | MQK | 162 | |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | MMX | 293 | |
| K223098 | Bakri Essential Postpartum Balloon | OQY | 28 | |
| K210734 | Endovascular Dilator and Sets | DRE | 26 | |
| K203670 | Extra Large Check-Flo Introducer | DYB | 62 | |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | LJE | 238 | |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | LJE | 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 | 30 | |
| K191163 | Lumax Guiding Catheter | DQY | 225 | |
| K190084 | McLean-Ring Enteral Feeding Tube Set | KNT | 267 |
Source: openFDA device/510k · retrieved
Where is Cook Incorporated registered?
FDA lists 5 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Cook Incorporated files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.