Equi-Tron Mfg., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Equi-Tron Mfg., Inc.” (first 1989, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
Review panels
- General Hospital (3)
- Anesthesiology (1)
- Physical Medicine (1)
Most recent Equi-Tron Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962763 | 2000 MODULAR THIRTY-NINE | FNL | 1996-10-07 | 83 |
| K903904 | SERIES 2000 ADJUSTABLE BED | FNL | 1990-10-12 | 50 |
| K903905 | SERIES 9000 LIFT-RECLINE CHAIR | INO | 1990-09-17 | 25 |
| K902089 | EQUI-GUARD (ASPIRATOR FILTER) | GCX | 1990-07-06 | 58 |
| K894831 | PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 | BTI | 1989-10-24 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Equi-Tron Mfg., 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 Equi-Tron Mfg., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Equi-Tron Mfg., 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 Equi-Tron Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Equi-Tron Mfg., Inc. is 58 days.
Which FDA product codes appear under Equi-Tron Mfg., Inc.?
The most frequent FDA product codes under this applicant name are FNL (Bed, Ac-Powered Adjustable Hospital, 2); BTI (Compressor, Air, Portable, 1); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 1).
Next steps
- See all 5 Equi-Tron Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNL, Equi-Tron Mfg., 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.