Hill-Med, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Hill-Med, Inc.” (first 1993, latest 2000), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 224 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HEX | Colposcope (And Colpomicroscope) | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 | 1 |
Review panels
Most recent Hill-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993991 | HM-930 ELECTROSURGICAL UNIT | GEI | 2000-05-30 | 188 |
| K981781 | ELECTROSURGICAL UNIT | GEI | 1998-12-04 | 198 |
| K961473 | HM-88011 SOLID STATE ELECTR SURGICAL UNIT | GEI | 1996-05-07 | 20 |
| K951718 | HM-SPIRO | BZG | 1995-12-20 | 251 |
| K940140 | HM-CRYO | GEH | 1994-06-27 | 167 |
| K932896 | HM-0690 COLPOSCOPE | HEX | 1994-03-23 | 282 |
| K932782 | HM-0660 | HEX | 1994-03-23 | 287 |
| K932817 | HM-880 I | GEI | 1994-03-09 | 273 |
| K932818 | HM-880 | GEI | 1994-02-25 | 261 |
| K932720 | HM-0970 | HRM | 1993-09-07 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Hill-Med, 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 Hill-Med, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Hill-Med, Inc.” (first 1993, latest 2000), across 5 product codes in 3 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 Hill-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hill-Med, Inc. is 224 days.
Which FDA product codes appear under Hill-Med, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); HEX (Colposcope (And Colpomicroscope), 2); BZG (Spirometer, Diagnostic, 1).
Next steps
- See all 10 Hill-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Hill-Med, 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.