FDA product code PEA: Endoscope, Accessories, Image Post-Processing For Color Enhancement
PEA is the FDA product code for endoscope, accessories, image post-processing for color enhancement. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under PEA, 2 in the last five years, from 4 different applicants. The average 510(k) review took 188 days (median 212); 53 days on average over the last three years. FDA has posted 4 recalls for PEA devices, 4 initiated in the last five years.
Definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Accessories, Image Post-Processing For Color Enhancement |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PEA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 214 |
| 2019 | 2 | 222 |
| 2023 | 1 | 88 |
| 2025 | 1 | 53 |
Compare with all 510(k) review times · Search every PEA clearance
Top PEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax of America, Inc. | 6 | 2025-06-03 |
| Endochoice, Inc. | 1 | 2016-08-01 |
| Fujifilm Medical Systems U.S.A, Inc. | 1 | 2014-08-22 |
| Pentax Medical | 1 | 2013-04-10 |
Most recent PEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251127 | Pentax of America, Inc. | PENTAX Medical Video Processor (EPK-i8020c) | 2025-06-03 | 53 |
| K231249 | Pentax of America, Inc. | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | 2023-07-28 | 88 |
| K190805 | Pentax of America, Inc. | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL | 2019-12-20 | 266 |
| K191282 | Pentax of America, Inc. | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | 2019-11-08 | 179 |
| K173679 | Pentax of America, Inc. | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | 2018-07-03 | 214 |
Recalls for PEA devices
4 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-07-16.
| Year | Recalls |
|---|---|
| 2025 | 4 |
Frequently asked questions
What is FDA product code PEA?
PEA is the FDA product code for endoscope, accessories, image post-processing for color enhancement. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PEA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEA?
Across 9 cleared submissions the average was 188 days from receipt to decision (median 212).
Which companies have the most PEA clearances?
Pentax of America, Inc. (6); Endochoice, Inc. (1); Fujifilm Medical Systems U.S.A, Inc. (1); Pentax Medical (1).
Have PEA devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2025-07-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PEA
- Run a recall and safety report across every PEA manufacturer
- Watch product code PEA 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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