FDA product code KNQ: Dilator, Esophageal
KNQ is the FDA product code for dilator, esophageal. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 40 510(k) submissions under KNQ, from 22 different applicants. The average 510(k) review took 153 days (median 88). FDA has posted 21 recalls for KNQ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Esophageal |
| Device class | Class II |
| Regulation | 21 CFR 876.5365 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KNQ clearance
Top KNQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 7 | 2012-10-24 |
| Medovations, Inc. | 3 | 2000-11-01 |
| Wilson-Cook Medical, Inc. | 3 | 1994-11-29 |
| Ethicon Endo-Surgery, Inc. | 2 | 2009-11-10 |
| Cook Endoscopy | 2 | 2009-09-25 |
17 more applicants have KNQ clearances. See the full list in Caduvo.
Most recent KNQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122924 | Boston Scientific Corp | CRE FIXED WIRE BALLON DILATION CATHETER | 2012-10-24 | 30 |
| K093236 | Ethicon Endo-Surgery, Inc. | ETHICON ENDO-SURGERYOPTICAL DILATOR | 2009-11-10 | 26 |
| K090183 | Cook Endoscopy | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | 2009-09-25 | 242 |
| K082995 | Safestitch Medical | SMART DILATOR | 2009-02-06 | 121 |
| K061937 | Cook Endoscopy | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | 2006-12-01 | 144 |
Recalls for KNQ devices
21 product recalls in 6 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-03-18.
| Year | Recalls |
|---|---|
| 2026 | 4 |
Frequently asked questions
What is FDA product code KNQ?
KNQ is the FDA product code for dilator, esophageal. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel.
What device class is KNQ?
Class II, regulation 21 CFR 876.5365. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNQ?
Across 40 cleared submissions the average was 153 days from receipt to decision (median 88).
Which companies have the most KNQ clearances?
Boston Scientific Corp (7); Medovations, Inc. (3); Wilson-Cook Medical, Inc. (3); Ethicon Endo-Surgery, Inc. (2); Cook Endoscopy (2).
Have KNQ devices been recalled?
Yes: 21 product recalls across 6 recall events; the most recent began 2026-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KNQ
- Run a recall and safety report across every KNQ manufacturer
- Watch product code KNQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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