Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841386KOLLMANN URETHRAL DILATORImm Enterprises , Ltd.1984-05-09430
K840311CAT. 7-EAR, NOSE & THROAT DEVICESImm Enterprises , Ltd.1984-05-091060
K841387WESTON RECTAL SNAREImm Enterprises , Ltd.1984-05-09430
K840304CATEGORY 17-MICROBIOLOGY DEVICESImm Enterprises , Ltd.1984-05-01980
K840305CATEGORY 1 CIRCULATORY SYSTEM DEVICEImm Enterprises , Ltd.1984-04-23900
K840318CAT. 14-CLINICAL TOXIOLOGY DEVICESImm Enterprises , Ltd.1984-04-23900
K840312CAT. 8 DENTAL DEVICESImm Enterprises , Ltd.1984-04-05720
K834171OP-CON SURG. INSTRUMENT #3Imm Enterprises , Ltd.1984-04-041350
K834191JAKOBI SURGICAL INSTRUMENTS #3 17/18/19Imm Enterprises , Ltd.1984-03-221220
K834192JAKOBI SURG. INSTRUMENTS #3 21/22/24Imm Enterprises , Ltd.1984-03-221220
K840310CATEGORY 6 OPTHALMIC DEVICESImm Enterprises , Ltd.1984-03-16520
K840319CAT 15-HEMATOLOGY & PATHOLOGY DEVICEImm Enterprises , Ltd.1984-03-12480
K840317CAT 13-CLINICAL CHEMISTRY DEVICESImm Enterprises , Ltd.1984-03-12480
K840306CATEGORY 2 GEN. HOSPITAL & PERSONAL USEImm Enterprises , Ltd.1984-03-12480
K840315CAT 11- GENERAL & PLASTIC SURGERY DEVImm Enterprises , Ltd.1984-03-12480
K840320CAT. 16-IMMUNOLOGY DEVICESImm Enterprises , Ltd.1984-03-12480
K840316CAT 12-ORTHOPEDIC & REHAB DEVICEImm Enterprises , Ltd.1984-03-12480
K840307CAT. 3 GASTROENTEROLOGY-UROLOGY DEVImm Enterprises , Ltd.1984-03-12480
K840309CAT. 5-RADIOLOGY DEVICESImm Enterprises , Ltd.1984-03-12480
K834190JAKOBI SURG. INSTRUMENTS #8 15Imm Enterprises , Ltd.1984-03-061060
K834188JAKOBI SURG. INSTRUMENTS #7 10/43Imm Enterprises , Ltd.1984-03-061060
K834172OP-CON SURG. INSTRUMENT #7Imm Enterprises , Ltd.1984-03-061060
K834540OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.1984-03-06960
K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.1984-03-061060
K840308CAT. 4-OBSTETRICS GYNECOLOGY DEV'SImm Enterprises , Ltd.1984-03-05410
K834187JAKOBI SURG. INSTRUMENTS #6 50Imm Enterprises , Ltd.1984-03-051050
K834178H.R. JAKOBI SURG. INSTR. #10 34/36Imm Enterprises , Ltd.1984-02-23940
K840314CAT 10-NEUROLOGY DEVICEImm Enterprises , Ltd.1984-02-23300
K834170OP-CON SURG. INSTRUMENT #10Imm Enterprises , Ltd.1984-02-23940
K834193JAKOBI SURG. INSTRUMENTS #2 70/71Imm Enterprises , Ltd.1984-02-10810
K840313CAT. 9 ANESTHESIOLOGY RESPIRATORY DEVImm Enterprises , Ltd.1984-02-04110
K834196JAKOBI SURG. INSTRUMENTS #11 20/25/27/37Imm Enterprises , Ltd.1984-01-27670
K834183H.R. JAKOBI SURG. INSTRUMENTS #11 25/39Imm Enterprises , Ltd.1984-01-27670
K834194JAKOBI SURG. INSTRUMENTS #1 19/10/26Imm Enterprises , Ltd.1984-01-27670
K834186JAKOBI SURG. INSTRUMENTS #11Imm Enterprises , Ltd.1984-01-27670
K834197JAKOBI SURG. INSTR- #11 38/39/45/46/67Imm Enterprises , Ltd.1984-01-27670
K834182H.R. JAKOBI SURG. INSTRUMENTS #11 27/37Imm Enterprises , Ltd.1984-01-27670
K834180H.R. JAKOBI SURG. INSTRUMENTS #11 13/20Imm Enterprises , Ltd.1984-01-27670
K834198JAKOBI SURG. INSTRUMENTS #12 40/41Imm Enterprises , Ltd.1984-01-27670
K834184H.R. JAKOBI SURG. INSTRUMENTS #11 38/67Imm Enterprises , Ltd.1984-01-27670
K834175OP-CON SURG. INSTRUMENTS #11Imm Enterprises , Ltd.1984-01-27670
K834195JAKOBI SURG. INSTRUMENTS #11 11/13/14Imm Enterprises , Ltd.1984-01-27670
K834541H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48Imm Enterprises , Ltd.1984-01-27670
K834176H.R. JAKOBI SURG. INSTRUMENTS 40/41Imm Enterprises , Ltd.1984-01-27670
K834185JAKOBI SURG. INSTRUMENTS #11 14/45Imm Enterprises , Ltd.1984-01-27670
K834542H.R. JAKOBI SURG. INSTRU. SECT. 48Imm Enterprises , Ltd.1984-01-27670
K834179H.R. JAKOBI SURG. INSTRUMENTS #9 48Imm Enterprises , Ltd.1984-01-27670
K834181H.R. JAKOBI SURG. INSTRUMENTS #11 16/46Imm Enterprises , Ltd.1984-01-27670
K834169OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.1984-01-17570
K834174OP-CON SURGICAL INSTRUMENTS #4Imm Enterprises , Ltd.1983-12-27360

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