I-Rep, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “I-Rep, Inc.” (first 1982, latest 1994), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| INQ | Table, Powered | 2 | 2 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ION | Exerciser, Non-Measuring | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent I-Rep, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930692 | LATHAM TABLE | INQ | 1994-02-02 | 357 |
| K930691 | ACCUTRAC TRACTION UNIT | ITH | 1993-07-22 | 162 |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | IMJ | 1986-07-14 | 60 |
| K854947 | REHABILITATION TABLES | INQ | 1986-01-03 | 24 |
| K851690 | ADJUSTABLE TREATMENT TABLES | — | 1985-05-07 | 21 |
| K842268 | VACUPULSE VACUUM UNIT | IPF | 1984-07-20 | 42 |
| K832940 | ROTAGYM | ISD | 1983-11-07 | 70 |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | ION | 1982-10-15 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named I-Rep, 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 I-Rep, Inc.?
FDA lists 8 510(k) clearances under the applicant name “I-Rep, Inc.” (first 1982, latest 1994), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I-Rep, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I-Rep, Inc. is 51 days.
Which FDA product codes appear under I-Rep, Inc.?
The most frequent FDA product codes under this applicant name are INQ (Table, Powered, 2); IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, 1); ION (Exerciser, Non-Measuring, 1).
Next steps
- See all 8 I-Rep, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INQ, I-Rep, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.