I M, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “I M, Inc.” (first 1976, latest 1992), across 29 product codes in 8 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 2 | 2 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 2 | 2 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 2 | 2 |
| HRQ | Hemostat | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 1 | 1 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 1 | 1 |
Plus 19 more product codes.
Review panels
- Microbiology (12)
- General and Plastic Surgery (7)
- General Hospital (5)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
- Neurology (1)
- Pathology (1)
Most recent I M, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | HBA | 1992-12-30 | 446 |
| K892389 | BIOPSY KIT | LRO | 1989-07-17 | 101 |
| K881363 | SYRINGE PREFILLED WITH WATER | KOD | 1988-06-23 | 84 |
| K880753 | UMBILICAL CORD CLAMP | HFW | 1988-04-27 | 62 |
| K872741 | NUTRIPUMP | FRN | 1987-10-20 | 102 |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | NAD | 1987-05-08 | 22 |
| K863785 | MAKLER CATHETER | HDR | 1986-12-11 | 76 |
| K854155 | STERILE SALINE SOLUTION | KMJ | 1985-12-10 | 60 |
| K853287 | HUBOUT | FPA | 1985-10-17 | 73 |
| K853288 | FEEDING UNITS & TUBES | KNT | 1985-10-04 | 38 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named I M, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under I M, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under I M, Inc.?
FDA lists 41 510(k) clearances under the applicant name “I M, Inc.” (first 1976, latest 1992), across 29 product codes in 8 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 I M, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I M, Inc. is 34 days.
Which FDA product codes appear under I M, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); GMG (Antigen, Latex Agglutination, Coccidioides Immitis, 2); GMJ (Antigens, Histoplasma Capsulatum, All, 2).
Next steps
- See all 41 I M, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, I M, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.