Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
I M, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
97 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | 1992-12-30 | 446 | 0 |
| K892389 | BIOPSY KIT | I M, Inc. | 1989-07-17 | 101 | 0 |
| K881363 | SYRINGE PREFILLED WITH WATER | I M, Inc. | 1988-06-23 | 84 | 0 |
| K880753 | UMBILICAL CORD CLAMP | I M, Inc. | 1988-04-27 | 62 | 0 |
| K872741 | NUTRIPUMP | I M, Inc. | 1987-10-20 | 102 | 0 |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | I M, Inc. | 1987-05-08 | 22 | 0 |
| K863785 | MAKLER CATHETER | I M, Inc. | 1986-12-11 | 76 | 0 |
| K854155 | STERILE SALINE SOLUTION | I M, Inc. | 1985-12-10 | 60 | 0 |
| K853287 | HUBOUT | I M, Inc. | 1985-10-17 | 73 | 0 |
| K853288 | FEEDING UNITS & TUBES | I M, Inc. | 1985-10-04 | 38 | 0 |
| K853286 | STAPLE REMOVER | I M, Inc. | 1985-08-21 | 16 | 0 |
| K844062 | FORCEPS & HAMOSTATS | I M, Inc. | 1985-01-18 | 92 | 0 |
| K844063 | SCISSORS GENERAL HOSPITAL | I M, Inc. | 1984-11-19 | 32 | 0 |
| K844152 | HEMSTATS | I M, Inc. | 1984-11-07 | 14 | 0 |
| K844151 | SETS AND TRAYS | I M, Inc. | 1984-11-07 | 14 | 0 |
| K833399 | SYRINGE | I M, Inc. | 1984-01-10 | 97 | 0 |
| K833435 | MULTI PURPOSE SYRINGE | I M, Inc. | 1983-12-12 | 68 | 0 |
| K831795 | FIRST AID KITS | I M, Inc. | 1983-09-01 | 90 | 0 |
| K831794 | SETS & TRAYS | I M, Inc. | 1983-08-16 | 74 | 0 |
| K831796 | URINE BAG SYSTEM | I M, Inc. | 1983-08-08 | 66 | 0 |
| K831798 | DISPOSABLE SCALPELS | I M, Inc. | 1983-07-19 | 46 | 0 |
| K831797 | HEMOSTATS | I M, Inc. | 1983-07-19 | 46 | 0 |
| K831799 | PLASTIC DISPOSABLE RAZOR | I M, Inc. | 1983-07-18 | 45 | 0 |
| K782070 | REAGENT, COCCI LATEX | I M, Inc. | 1979-02-01 | 51 | 0 |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | I M, Inc. | 1978-04-28 | 28 | 0 |
| K770527 | CANDIDA IMMUNODIFFUSION KIT | I M, Inc. | 1978-03-17 | 364 | 0 |
| K760837 | POTASSIUM HYDROXIDE W/GLYCEROL MTG FL. | I M, Inc. | 1976-11-16 | 34 | 0 |
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | I M, Inc. | 1976-11-16 | 34 | 0 |
| K760839 | VASPAR, SEALANT FOR FERMENTATIONS | I M, Inc. | 1976-11-16 | 34 | 0 |
| K760825 | FUNGAL IMMUNODIFFUSION KIT | I M, Inc. | 1976-11-16 | 34 | 0 |
| K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760828 | BLASTOMYCES YEAST ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760827 | HISTOPLASMA YEAST ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760830 | ASPERGILLUS MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760826 | HISTOPLASMA MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760836 | NEGATIVE CONTROL SERUM | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760829 | COCCIDIOIDES MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760833 | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | I M, Inc. | 1976-11-01 | 19 | 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