Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airstrip Technologies, LP — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
185 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133450 | AIRSTRIP REMOTE PATIENT MONITORING | Airstrip Technologies, LP | 2014-02-14 | 95 | 0 |
| K133394 | AIRSTRIP REMOTE PATIENT MONITORING | Airstrip Technologies, LP | 2014-02-06 | 93 | 0 |
| K131786 | AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER | Airstrip Technologies, LP | 2013-07-03 | 15 | 0 |
| K122133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2012-10-02 | 76 | 0 |
| K121871 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2012-07-03 | 6 | 0 |
| K112235 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2011-08-26 | 22 | 0 |
| K110503 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) | Airstrip Technologies, LP | 2011-03-10 | 16 | 0 |
| K100133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Airstrip Technologies, LP | 2010-07-23 | 185 | 0 |
| K090269 | AIRSTRIP OB | Airstrip Technologies, LP | 2009-02-13 | 10 | 0 |
| K090061 | AIRSTRIP OB | Airstrip Technologies, LP | 2009-01-23 | 14 | 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