Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airstrip Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
174 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211949 | AirStrip ONE Web Client with Alarm Communication Management | Airstrip Technologies, Inc. | 2021-12-09 | 169 | 0 |
| K182226 | AirStrip RPM InvisionHeart Adapter | Airstrip Technologies, Inc. | 2018-09-11 | 26 | 0 |
| K160862 | AirStrip RPM | Airstrip Technologies, Inc. | 2016-09-19 | 174 | 0 |
| K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015-03-10 | 131 | 1 |
| K121712 | AIRSTRIP RPM FOR LIFENET CONSULT | Airstrip Technologies, Inc. | 2012-11-20 | 162 | 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