Sorex Medical: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sorex Medical” (first 1989, latest 1994), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| LDQ | 1 | 1 | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| LZM | Guard, Skin Graft | 1 | 1 |
| MCY | Wound Dressing Kit | 1 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
- General Hospital (3)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
Most recent Sorex Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923843 | FOGLESS | OCT | 1994-03-25 | 602 |
| K913036 | PLUME MASTER | FYD | 1991-09-06 | 59 |
| K911070 | PICC-FIX | KMK | 1991-07-05 | 116 |
| K911150 | SOREX SAFE-AIR | GEX | 1991-06-28 | 105 |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | LJS | 1991-04-05 | 71 |
| K905572 | EDLICH WOUND MANAGEMENT TRAY | MCY | 1991-03-12 | 90 |
| K903740 | TRACH-EZE | BSY | 1990-12-06 | 112 |
| K902410 | MEDICAL PROCEDURE TRAY | LDQ | 1990-11-20 | 173 |
| K885136 | GRAFT GUARD | LZM | 1989-02-06 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Sorex Medical.
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 Sorex Medical?
FDA lists 9 510(k) clearances under the applicant name “Sorex Medical” (first 1989, latest 1994), across 9 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 Sorex Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorex Medical is 105 days.
Which FDA product codes appear under Sorex Medical?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 1); FYD (Apparatus, Exhaust, Surgical, 1); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 9 Sorex Medical clearances with predicates and recalls
- Run predicate analysis for product code BSY, Sorex Medical'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.