Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neoforce Group, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
143 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110119 | PRESSURE MANOMETER | Neoforce Group, Inc. | 2011-06-10 | 143 | 0 |
| K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | Neoforce Group, Inc. | 2011-04-20 | 111 | 0 |
| K102649 | NEOPOP INFANT RESUSCITATOR WITH FLOW METER | Neoforce Group, Inc. | 2011-01-06 | 114 | 0 |
| K092085 | ISPIRA RESUSCITATION UNIT | Neoforce Group, Inc. | 2009-10-07 | 90 | 0 |
| K072021 | NEOPIP INFANT RESUSCITATOR | Neoforce Group, Inc. | 2007-09-12 | 51 | 0 |
| K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | Neoforce Group, Inc. | 2007-05-29 | 106 | 0 |
| K061280 | V-2200 INFANT INCUBATOR | Neoforce Group, Inc. | 2006-06-27 | 50 | 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