International Medical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “International Medical Products, Inc.” (first 1986, latest 1998), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 3 | 3 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 | 1 |
| FKP | System, Dialysate Delivery, Single Patient | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KNN | Components, Wheelchair | 1 | 1 |
| KZE | Injector, Fluid, Non-Electrically Powered | 1 | 1 |
Review panels
- Gastroenterology and Urology (4)
- General Hospital (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent International Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES | KPO | 1998-06-16 | 90 |
| K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | KPO | 1997-10-30 | 62 |
| K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | KPO | 1997-06-16 | 84 |
| K920077 | NIKKISO NK PUMP | DWD | 1993-09-29 | 630 |
| K923942 | RHOMBO MEDICAL RHOMBO-FILL | KNN | 1993-03-24 | 231 |
| K900755 | DIGITAL CUFF PV GAUGE | BSK | 1990-04-26 | 69 |
| K864984 | ROBINJECT | KZE | 1987-06-29 | 189 |
| K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 | FKP | 1987-02-25 | 162 |
| K861539 | NIKKISO INFUSION PUMP MODEL PFA-02 | FRN | 1986-07-31 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named International Medical Products, 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 International Medical Products, 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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- International Technidyne Corp. (48 510(k)s)
- International Imaging Electronics (19 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Medical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “International Medical Products, Inc.” (first 1986, latest 1998), across 7 product codes in 5 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 International Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Medical Products, Inc. is 98 days.
Which FDA product codes appear under International Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 3); BSK (Cuff, Tracheal Tube, Inflatable, 1); DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass, 1).
Next steps
- See all 9 International Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPO, International Medical Products, 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.