Aaron Medical Industries: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Aaron Medical Industries” (first 1990, latest 2006), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 88 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 | 27 | 27 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 4 | 4 |
| JOS | Electrode, Electrosurgical | 3 | 3 |
| ETN | Stimulator, Nerve | 2 | 2 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FSQ | Light, Surgical, Instrument | 1 | 1 |
| GFE | Brush, Dermabrasion, Powered | 1 | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 1 |
| HOG | Burr, Corneal, Battery-Powered | 1 | 1 |
Plus 3 more product codes.
Review panels
- General and Plastic Surgery (32)
- Ophthalmic (7)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (2)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Aaron Medical Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062337 | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR | GEI | 2006-10-05 | 56 |
| K061307 | BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK | GEI | 2006-07-18 | 69 |
| K060117 | BOVIE BUTTON REMOTE HAND SWITCH | GEI | 2006-02-22 | 36 |
| K022856 | BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | 2003-02-10 | 167 |
| K021817 | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V | GEI | 2002-07-11 | 38 |
| K020579 | AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 | GEI | 2002-05-13 | 81 |
| K014201 | AARON REUSABLE ELECTROSURGICAL ELECTRODE | GEI | 2002-02-25 | 66 |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | GEI | 2000-12-22 | 178 |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | 2000-06-27 | 56 |
| K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | GEI | 2000-04-19 | 26 |
36 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-06-29.
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.
- Aaron Medical, Inc. (3 510(k)s)
- Aaron Laboratories, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aaron Medical Industries?
FDA lists 46 510(k) clearances under the applicant name “Aaron Medical Industries” (first 1990, latest 2006), across 13 product codes in 6 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 Aaron Medical Industries?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aaron Medical Industries is 88 days.
Which FDA product codes appear under Aaron Medical Industries?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 27); HQP (Unit, Cautery, Thermal, Battery-Powered, 4); JOS (Electrode, Electrosurgical, 3).
Next steps
- See all 46 Aaron Medical Industries clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aaron Medical Industries'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.