Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Biomedical — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
276 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022-10-07 | 169 | 0 |
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 | 121 | 0 |
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022-07-15 | 123 | 0 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020-03-10 | 84 | 0 |
| K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | 2019-01-18 | 86 | 0 |
| K173516 | NuBorne Infant Warmer | International Biomedical | 2018-08-17 | 276 | 0 |
| K160238 | Airborne Phototherapy Light | International Biomedical | 2016-06-14 | 134 | 0 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | International Biomedical | 2014-05-28 | 69 | 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