Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BXR · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
165 daysmedian FDA review time
194 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Instrumentation Industries, Inc. | 2008-09-11 | 86 | 0 |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE | Mercury Medical | 2004-02-03 | 165 | 0 |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Warren E. Collins, Inc. | 1992-01-15 | 194 | 0 |
| K904917 | THAYER MIP ADAPTER | Thayer Medical Corp. | 1991-01-28 | 89 | 0 |
| K901998 | DIGITAL MANOMETER (DM 50) | Medical Support Products, Inc. | 1990-07-25 | 84 | 0 |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 | 191 | 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