Lorrex Health Products: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Lorrex Health Products” (first 1993, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 9 | 9 |
| EFQ | Gauze/Sponge, Internal | 6 | 6 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
Review panels
Most recent Lorrex Health Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945866 | CYLINDRICAL SPONGE | GDY | 1994-12-28 | 27 |
| K945606 | TRIANGULAR SPONGES | GDY | 1994-12-28 | 43 |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | GDY | 1994-12-28 | 48 |
| K945335 | CHERRY DISSECTOR | GDY | 1994-12-28 | 57 |
| K945333 | KITTNER DISSECTOR | GDY | 1994-12-28 | 57 |
| K945336 | PEANUT DISSECTOR | GDY | 1994-12-05 | 34 |
| K945334 | CHERRY PIT DISSECTOR | GDY | 1994-12-05 | 34 |
| K945332 | ROSEBUD DISSECTOR | GDY | 1994-12-05 | 34 |
| K942824 | LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S | EFQ | 1994-08-03 | 50 |
| K942314 | LORREX GAUZE SPONGES SPECIALTY | EFQ | 1994-06-02 | 20 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lorrex Health Products.
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 Lorrex Health Products?
FDA lists 16 510(k) clearances under the applicant name “Lorrex Health Products” (first 1993, latest 1994), across 3 product codes in 2 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 Lorrex Health Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lorrex Health Products is 34 days.
Which FDA product codes appear under Lorrex Health Products?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 9); EFQ (Gauze/Sponge, Internal, 6); FLK (Thermometer, Clinical Mercury, 1).
Next steps
- See all 16 Lorrex Health Products clearances with predicates and recalls
- Run predicate analysis for product code GDY, Lorrex Health Products'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.