Imm Enterprises , Ltd.: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Imm Enterprises , Ltd.” (first 1983, latest 1984), across 29 product codes in 10 review panels. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| HTD | Forceps | 14 | 14 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 4 | 4 |
| GES | Blade, Scalpel | 3 | 3 |
| GWZ | Percussor | 3 | 3 |
| BWB | Forceps, Tube Introduction | 2 | 2 |
| EMF | Knife, Surgical | 2 | 2 |
| GAD | Retractor | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| EMG | Forceps, Tooth Extractor, Surgical | 1 | 1 |
Plus 19 more product codes.
Review panels
- General and Plastic Surgery (26)
- Gastroenterology and Urology (5)
- Ear, Nose and Throat (4)
- Obstetrics and Gynecology (4)
- Anesthesiology (3)
- Neurology (3)
- Dental (2)
- Ophthalmic (2)
- Cardiovascular (1)
- General Hospital (1)
Most recent Imm Enterprises , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841387 | WESTON RECTAL SNARE | KOA | 1984-05-09 | 43 |
| K841386 | KOLLMANN URETHRAL DILATOR | KOE | 1984-05-09 | 43 |
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | KCP | 1984-05-09 | 106 |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | HTD | 1984-05-01 | 98 |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | HTD | 1984-04-23 | 90 |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | DWS | 1984-04-23 | 90 |
| K840312 | CAT. 8 DENTAL DEVICES | EMG | 1984-04-05 | 72 |
| K834171 | OP-CON SURG. INSTRUMENT #3 | KOA | 1984-04-04 | 135 |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | KOA | 1984-03-22 | 122 |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | KOA | 1984-03-22 | 122 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imm Enterprises , Ltd..
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 Imm Enterprises , Ltd.?
FDA lists 52 510(k) clearances under the applicant name “Imm Enterprises , Ltd.” (first 1983, latest 1984), across 29 product codes in 10 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 Imm Enterprises , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imm Enterprises , Ltd. is 67 days.
Which FDA product codes appear under Imm Enterprises , Ltd.?
The most frequent FDA product codes under this applicant name are HTD (Forceps, 14); KOA (Surgical Instruments, G-U, Manual (And Accessories), 4); GES (Blade, Scalpel, 3).
Next steps
- See all 52 Imm Enterprises , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HTD, Imm Enterprises , Ltd.'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.