FDA product code NZA: Accessories, Germicide, Cleaning, For Endoscopes
NZA is the FDA product code for accessories, germicide, cleaning, for endoscopes. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel. FDA has cleared 11 510(k) submissions under NZA, 3 in the last five years, from 3 different applicants. The average 510(k) review took 112 days (median 108). FDA has posted 1 recall for NZA devices.
Definition
High level disinfection of reusable, heat-sensitive devices 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).
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Germicide, Cleaning, For Endoscopes |
| 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 NZA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 29 |
| 2021 | 1 | 87 |
| 2022 | 1 | 30 |
| 2023 | 2 | 78 |
Compare with all 510(k) review times · Search every NZA clearance
Top NZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 8 | 2023-10-03 |
| Keymed, Inc. | 2 | 1986-06-17 |
| Steris | 1 | 2021-01-28 |
Most recent NZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232918 | STERIS Corporation | enspire 300 Series Automated Endoscope Reprocessor | 2023-10-03 | 14 |
| K230560 | STERIS Corporation | enspire 300 Series Automated Endoscope Reprocessor System | 2023-07-21 | 143 |
| K220361 | STERIS Corporation | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | 2022-03-10 | 30 |
| K203223 | Steris | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | 2021-01-28 | 87 |
| K200989 | STERIS Corporation | Reliance Endoscope Processing System | 2020-05-14 | 29 |
Recalls for NZA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-29.
Frequently asked questions
What is FDA product code NZA?
NZA is the FDA product code for accessories, germicide, cleaning, for endoscopes. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel.
What device class is NZA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZA?
Across 11 cleared submissions the average was 112 days from receipt to decision (median 108).
Which companies have the most NZA clearances?
STERIS Corporation (8); Keymed, Inc. (2); Steris (1).
Have NZA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code NZA
- Run a recall and safety report across every NZA manufacturer
- Watch product code NZA 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times