International Biophysics Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “International Biophysics Corp.” (first 1996, latest 2021), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 186 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 | 1 | 225 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 345 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 435 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name International Biophysics Corp. took a median 390 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 | 3 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | 2 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 1 | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent International Biophysics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193663 | FloPump 57mL Centrifugal Pump | KFM | 2021-03-10 | 435 |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | KFM | 2017-12-15 | 345 |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | BYI | 2013-03-27 | 225 |
| K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | CAW | 2008-01-11 | 109 |
| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | GEX | 2003-04-17 | 90 |
| K992657 | IBC VRV, MODEL 1350 | DWD | 2000-02-18 | 193 |
| K992785 | IBC FLOGUARD, MODEL 6050 | MJJ | 2000-01-14 | 148 |
| K992964 | IBC VENT VALVE, MODEL 1400 | MNJ | 1999-11-19 | 78 |
| K983272 | IBC FLOPUMP, MODEL 6000 | KFM | 1999-03-24 | 188 |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | DPT | 1998-04-08 | 569 |
4 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2015-08-07.
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.
Device clinical trials
An industry sponsor named International Biophysics Corp. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03628456: Effect of HFCWO Vests on Spirometry Measurements (Completed, started 2018-09-13)
- NCT03534986: Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements (Completed, started 2018-02-20)
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 Medsurg Connection (13 510(k)s)
- International Medical Products, Inc. (9 510(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 Biophysics Corp.?
FDA lists 14 510(k) clearances under the applicant name “International Biophysics Corp.” (first 1996, latest 2021), across 11 product codes in 3 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 Biophysics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Biophysics Corp. is 186 days.
Which FDA product codes appear under International Biophysics Corp.?
The most frequent FDA product codes under this applicant name are KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 3); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 2); BYI (Percussor, Powered-Electric, 1).
Next steps
- See all 14 International Biophysics Corp. clearances with predicates and recalls
- Run predicate analysis for product code KFM, International Biophysics Corp.'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.