Sentry Medical Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Sentry Medical Products, Inc.” (first 1983, latest 1996), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 120 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| JOS | Electrode, Electrosurgical | 1 | 1 |
Review panels
Most recent Sentry Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962122 | SENTRY RADIOTRANSLUCENT ECG ELECTRODES | DRX | 1996-07-24 | 54 |
| K955636 | SENTRY DISPOSABLE DISPERSIVE ELECTRODE | JOS | 1996-03-27 | 107 |
| K942827 | SENTRY INSERTION TRAY | FOS | 1994-11-02 | 141 |
| K934000 | SENTRY AQUEOUS GEL ECG ELECTRODES | DRX | 1994-08-30 | 378 |
| K935098 | BABY BOARD | BTX | 1994-02-15 | 113 |
| K933603 | LEADWIRE | DSA | 1994-01-18 | 175 |
| K932704 | PATIENT CABLE | DSA | 1993-12-27 | 207 |
| K881670 | ACCUTEMP PLUS | FMT | 1988-11-22 | 218 |
| K881343 | DURADERM BUTTERFLY | GXY | 1988-05-04 | 35 |
| K851522 | DIAGNOSTIC ECG DISPOSABLE ELECTRODE | DRX | 1985-10-24 | 192 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sentry Medical Products, 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 Sentry Medical Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Sentry Medical Products, Inc.” (first 1983, latest 1996), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sentry Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sentry Medical Products, Inc. is 120 days.
Which FDA product codes appear under Sentry Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 5); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2); GXY (Electrode, Cutaneous, 2).
Next steps
- See all 13 Sentry Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Sentry Medical Products, 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.