Np Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Np Medical, Inc.” (first 1998, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 154 days. Since 2017 the median was 194 days, against 157 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 96 |
| 2022 | 1 | 162 |
| 2023 | 1 | 442 |
| 2024 | 0 | — |
| 2025 | 1 | 225 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Np Medical, Inc. took a median 194 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 5 | 5 |
| FXX | Mask, Surgical | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Np Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | FPA | 2025-12-04 | 225 |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | FPA | 2023-04-19 | 442 |
| K221518 | NP Medical nCompass Extension Set with Stabilizing Base | FPA | 2022-11-03 | 162 |
| K203265 | nPro Surgical Mask | FXX | 2021-02-09 | 96 |
| K130023 | K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR | FPA | 2013-04-03 | 90 |
| K973916 | NP MEDICAL CAPLESS LUER ACTIVATED VALVE | FPA | 1998-03-09 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Np Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Np Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Np Medical, Inc.” (first 1998, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Np Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Np Medical, Inc. is 154 days. Since 2017: 194 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Np Medical, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); FXX (Mask, Surgical, 1).
Next steps
- See all 6 Np Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Np Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.