International Biomedical: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “International Biomedical” (first 1996, latest 2022), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 134 days. Since 2017 the median was 122 days, against 162 days for all cleared 510(k)s in the same product codes. 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 | 1 | 69 |
| 2015 | 0 | — |
| 2016 | 1 | 134 |
| 2017 | 0 | — |
| 2018 | 1 | 276 |
| 2019 | 1 | 86 |
| 2020 | 1 | 84 |
| 2021 | 0 | — |
| 2022 | 3 | 123 |
| 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 Biomedical took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPL | Incubator, Neonatal Transport | 7 | 7 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 | 2 |
| MRN | Apparatus, Nitric Oxide Delivery | 2 | 2 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | 1 | 1 |
Review panels
- General Hospital (11)
- Anesthesiology (4)
- Physical Medicine (2)
Most recent International Biomedical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | MPO | 2022-10-07 | 169 |
| K221653 | InfaTherm Disposable Infant Warming Mattress | IMD | 2022-10-06 | 121 |
| K220742 | NxtGen Infant Transport Incubator | FPL | 2022-07-15 | 123 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | MRN | 2020-03-10 | 84 |
| K182956 | Puffin Lite Infant Resuscitation System | BTL | 2019-01-18 | 86 |
| K173516 | NuBorne Infant Warmer | FMT | 2018-08-17 | 276 |
| K160238 | Airborne Phototherapy Light | LBI | 2016-06-14 | 134 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | BTL | 2014-05-28 | 69 |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | FPL | 2011-05-11 | 161 |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | FPL | 2011-05-11 | 161 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-05-24.
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.
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 Biophysics Corp. (14 510(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 Biomedical?
FDA lists 17 510(k) clearances under the applicant name “International Biomedical” (first 1996, latest 2022), across 9 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 Biomedical?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Biomedical is 134 days. Since 2017: 122 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under International Biomedical?
The most frequent FDA product codes under this applicant name are FPL (Incubator, Neonatal Transport, 7); BTL (Ventilator, Emergency, Powered (Resuscitator), 2); MRN (Apparatus, Nitric Oxide Delivery, 2).
Next steps
- See all 17 International Biomedical clearances with predicates and recalls
- Run predicate analysis for product code FPL, International Biomedical'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.