Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A Plus Medical — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
231 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | A Plus Medical | 2012-01-13 | 87 | 0 |
| K110471 | BABI PLUS INFANT NASAL CANNULA SYSTEM | A Plus Medical | 2011-10-07 | 231 | 0 |
| K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 1 | A Plus Medical | 2011-08-01 | 172 | 4 |
| K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOS | A Plus Medical | 2010-11-18 | 90 | 0 |
| K093716 | BABI PLUS INFANT NASAL CANNULA SYSTEM | A Plus Medical | 2010-05-13 | 162 | 0 |
| K092687 | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | A Plus Medical | 2009-11-23 | 83 | 0 |
| K090317 | BABI*PLUS BUBBLE PAP VALVE | A Plus Medical | 2009-05-20 | 100 | 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