Imm Enterprises , Ltd.: FDA clearances and approvals
Imm Enterprises , Ltd. has 52 FDA 510(k) clearances (first 1983, latest 1984), across 29 product codes in 10 review panels. Median 510(k) review time: 67 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Imm Enterprises , Ltd. have?
Imm Enterprises , Ltd. has 52 FDA 510(k) clearances (first 1983, latest 1984), across 29 product codes in 10 review panels.
How long does FDA take to clear Imm Enterprises , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Imm Enterprises , Ltd.'s cleared 510(k)s is 67 days.
What devices does Imm Enterprises , Ltd. make?
Its most frequent FDA product codes are HTD (Forceps, 14); KOA (Surgical Instruments, G-U, Manual (And Accessories), 4); GES (Blade, Scalpel, 3).
Has Imm Enterprises , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Imm Enterprises , Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.