Devon Industries, Inc.: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Devon Industries, Inc.” (first 1976, latest 1996), across 26 product codes in 5 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| LDQ | 4 | 4 | |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FSE | Table, Operating-Room, Manual | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| KDC | Instrument, Surgical, Disposable | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 2 | 2 |
| FWZ | Operating Room Accessories Table Tray | 2 | 2 |
| FZZ | Marker, Skin | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| LWH | Counter, Sponge, Surgical | 2 | 2 |
Plus 16 more product codes.
Review panels
- General and Plastic Surgery (20)
- General Hospital (13)
- Anesthesiology (3)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent Devon Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | MLS | 1996-07-03 | 43 |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | CBT | 1995-11-20 | 87 |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | FMI | 1995-07-10 | 195 |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | MMK | 1994-12-02 | 39 |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | FMI | 1994-12-02 | 101 |
| K943892 | POINT OF USE SHARPS A GATOR | FMI | 1994-12-02 | 115 |
| K945485 | ABG NEEDLE PROTECTION | CBT | 1994-11-29 | 21 |
| K932998 | EASY-ON | GES | 1993-08-18 | 61 |
| K912824 | DEVON SPONGE COUNTER BAGS | LWH | 1991-08-26 | 61 |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | KME | 1989-09-07 | 84 |
37 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Devon Industries, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Devon Medical, Inc. (13 510(k)s)
- Devon Medical Products (6 510(k)s)
- Devon Medical Products (Jiangsu), Ltd. (6 510(k)s)
- Devon Safety Products, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Devon Industries, Inc.?
FDA lists 47 510(k) clearances under the applicant name “Devon Industries, Inc.” (first 1976, latest 1996), across 26 product codes in 5 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 Devon Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devon Industries, Inc. is 59 days.
Which FDA product codes appear under Devon Industries, Inc.?
The most frequent FDA product codes under this applicant name are LDQ (device, 4); FMI (Needle, Hypodermic, Single Lumen, 3); FSE (Table, Operating-Room, Manual, 3).
Next steps
- See all 47 Devon Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LDQ, Devon Industries, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.