Holl Meditronics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Holl Meditronics, Inc.” (first 1989, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 185 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 3 | 3 |
| BXB | Exerciser, Powered | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
Review panels
Most recent Holl Meditronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954171 | ARCO-MBC, ARCO MC | GEI | 1996-04-30 | 238 |
| K942095 | SONOCA III | LFL | 1994-11-09 | 203 |
| K911600 | ILCO INFRARED LIGHT COAGULATOR | KNS | 1991-07-09 | 90 |
| K893924 | MOTO-MED RF-II AND PICO | BXB | 1990-11-27 | 545 |
| K901737 | SONOCA II ULTRASONIC SURGICAL DEVICE | LFL | 1990-07-03 | 77 |
| K893926 | SONOCA ULTRASONIC SURGICAL SYSTEM | LFL | 1989-11-14 | 167 |
Recalls
openFDA lists no recalls under a recalling firm named Holl Meditronics, 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 Holl Meditronics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Holl Meditronics, Inc.” (first 1989, latest 1996), across 4 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 Holl Meditronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Holl Meditronics, Inc. is 185 days.
Which FDA product codes appear under Holl Meditronics, Inc.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 3); BXB (Exerciser, Powered, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 6 Holl Meditronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFL, Holl Meditronics, 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.