FDA product code NVE: Washer, Cleaner, Automated, Endoscope
NVE is the FDA product code for washer, cleaner, automated, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel. FDA has cleared 12 510(k) submissions under NVE, 2 in the last five years, from 9 different applicants. The average 510(k) review took 136 days (median 144). FDA has posted 1 recall for NVE devices.
Definition
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes.
Classification
| Field | Value |
|---|---|
| Device name | Washer, Cleaner, Automated, Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | HO — General Hospital |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NVE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 217 |
| 2020 | 2 | 31 |
| 2022 | 2 | 6 |
Compare with all 510(k) review times · Search every NVE clearance
Top NVE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 3 | 2020-12-01 |
| Steris | 2 | 2022-09-30 |
| Intuitive Surgical, Inc. | 1 | 2008-08-01 |
| Langford IC Systems, Inc. | 1 | 2005-06-20 |
| Custom Ultrasonics | 1 | 1998-09-22 |
4 more applicants have NVE clearances. See the full list in Caduvo.
Most recent NVE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222849 | Steris | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | 2022-09-30 | 9 |
| K222543 | Steris | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | 2022-08-25 | 3 |
| K203199 | STERIS Corporation | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | 2020-12-01 | 33 |
| K200577 | STERIS Corporation | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | 2020-04-03 | 29 |
| K190081 | STERIS Corporation | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | 2019-08-21 | 217 |
Recalls for NVE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-05-06.
Frequently asked questions
What is FDA product code NVE?
NVE is the FDA product code for washer, cleaner, automated, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel.
What device class is NVE?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVE?
Across 12 cleared submissions the average was 136 days from receipt to decision (median 144).
Which companies have the most NVE clearances?
STERIS Corporation (3); Steris (2); Intuitive Surgical, Inc. (1); Langford IC Systems, Inc. (1); Custom Ultrasonics (1).
Have NVE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NVE
- Run a recall and safety report across every NVE manufacturer
- Watch product code NVE 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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