Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imm Enterprises , Ltd. — Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
106 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841386 | KOLLMANN URETHRAL DILATOR | Imm Enterprises , Ltd. | 1984-05-09 | 43 | 0 |
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | Imm Enterprises , Ltd. | 1984-05-09 | 106 | 0 |
| K841387 | WESTON RECTAL SNARE | Imm Enterprises , Ltd. | 1984-05-09 | 43 | 0 |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | Imm Enterprises , Ltd. | 1984-05-01 | 98 | 0 |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | Imm Enterprises , Ltd. | 1984-04-23 | 90 | 0 |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Imm Enterprises , Ltd. | 1984-04-23 | 90 | 0 |
| K840312 | CAT. 8 DENTAL DEVICES | Imm Enterprises , Ltd. | 1984-04-05 | 72 | 0 |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Imm Enterprises , Ltd. | 1984-04-04 | 135 | 0 |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Imm Enterprises , Ltd. | 1984-03-22 | 122 | 0 |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Imm Enterprises , Ltd. | 1984-03-22 | 122 | 0 |
| K840310 | CATEGORY 6 OPTHALMIC DEVICES | Imm Enterprises , Ltd. | 1984-03-16 | 52 | 0 |
| K840319 | CAT 15-HEMATOLOGY & PATHOLOGY DEVICE | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840317 | CAT 13-CLINICAL CHEMISTRY DEVICES | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840306 | CATEGORY 2 GEN. HOSPITAL & PERSONAL USE | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840315 | CAT 11- GENERAL & PLASTIC SURGERY DEV | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840320 | CAT. 16-IMMUNOLOGY DEVICES | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840316 | CAT 12-ORTHOPEDIC & REHAB DEVICE | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840307 | CAT. 3 GASTROENTEROLOGY-UROLOGY DEV | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K840309 | CAT. 5-RADIOLOGY DEVICES | Imm Enterprises , Ltd. | 1984-03-12 | 48 | 0 |
| K834190 | JAKOBI SURG. INSTRUMENTS #8 15 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K834188 | JAKOBI SURG. INSTRUMENTS #7 10/43 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K834172 | OP-CON SURG. INSTRUMENT #7 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K834540 | OP-CON SURGICAL INSTRUMENT #9 | Imm Enterprises , Ltd. | 1984-03-06 | 96 | 0 |
| K834189 | JAKOBI SURG. INSTRUMENTS #7 44/47 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | 1984-03-05 | 41 | 0 |
| K834187 | JAKOBI SURG. INSTRUMENTS #6 50 | Imm Enterprises , Ltd. | 1984-03-05 | 105 | 0 |
| K834178 | H.R. JAKOBI SURG. INSTR. #10 34/36 | Imm Enterprises , Ltd. | 1984-02-23 | 94 | 0 |
| K840314 | CAT 10-NEUROLOGY DEVICE | Imm Enterprises , Ltd. | 1984-02-23 | 30 | 0 |
| K834170 | OP-CON SURG. INSTRUMENT #10 | Imm Enterprises , Ltd. | 1984-02-23 | 94 | 0 |
| K834193 | JAKOBI SURG. INSTRUMENTS #2 70/71 | Imm Enterprises , Ltd. | 1984-02-10 | 81 | 0 |
| K840313 | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | Imm Enterprises , Ltd. | 1984-02-04 | 11 | 0 |
| K834196 | JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834183 | H.R. JAKOBI SURG. INSTRUMENTS #11 25/39 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834194 | JAKOBI SURG. INSTRUMENTS #1 19/10/26 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834186 | JAKOBI SURG. INSTRUMENTS #11 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834182 | H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834180 | H.R. JAKOBI SURG. INSTRUMENTS #11 13/20 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834198 | JAKOBI SURG. INSTRUMENTS #12 40/41 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834195 | JAKOBI SURG. INSTRUMENTS #11 11/13/14 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834176 | H.R. JAKOBI SURG. INSTRUMENTS 40/41 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834185 | JAKOBI SURG. INSTRUMENTS #11 14/45 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834542 | H.R. JAKOBI SURG. INSTRU. SECT. 48 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834179 | H.R. JAKOBI SURG. INSTRUMENTS #9 48 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834181 | H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834169 | OP-CON SURGICAL INSTRUMENT #9 | Imm Enterprises , Ltd. | 1984-01-17 | 57 | 0 |
| K834174 | OP-CON SURGICAL INSTRUMENTS #4 | Imm Enterprises , Ltd. | 1983-12-27 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda