Airstrip Technologies, LP: FDA clearances and approvals
Airstrip Technologies, LP has 15 FDA 510(k) clearances (first 2009, latest 2021), across 4 product codes in 2 review panels. Median 510(k) review time: 76 days. openFDA lists 1 product recall by a recalling firm named Airstrip Technologies, LP.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 76 |
| 2013 | 1 | 15 |
| 2014 | 2 | 94 |
| 2015 | 1 | 131 |
| 2016 | 1 | 174 |
| 2017 | 0 | — |
| 2018 | 1 | 26 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 169 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Airstrip Technologies, LP's cleared 510(k)s took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 9 | 9 |
| MSX | System, Network And Communication, Physiological Monitors | 3 | 3 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| LQK | Home Uterine Activity Monitor | 1 | 1 |
Review panels
Most recent Airstrip Technologies, LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | MSX | 2021-12-09 | 169 |
| K182226 | AirStrip RPM InvisionHeart Adapter | MWI | 2018-09-11 | 26 |
| K160862 | AirStrip RPM | MSX | 2016-09-19 | 174 |
| K143114 | Sense4Baby System Model B+ (MSA) | LQK | 2015-03-10 | 131 |
| K133450 | AIRSTRIP REMOTE PATIENT MONITORING | MWI | 2014-02-14 | 95 |
| K133394 | AIRSTRIP REMOTE PATIENT MONITORING | MWI | 2014-02-06 | 93 |
| K131786 | AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER | MWI | 2013-07-03 | 15 |
| K121712 | AIRSTRIP RPM FOR LIFENET CONSULT | MSX | 2012-11-20 | 162 |
| K122133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | MWI | 2012-10-02 | 76 |
| K121871 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | MWI | 2012-07-03 | 6 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-08-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Airstrip Technologies, LP have?
Airstrip Technologies, LP has 15 FDA 510(k) clearances (first 2009, latest 2021), across 4 product codes in 2 review panels.
How long does FDA take to clear Airstrip Technologies, LP's 510(k)s?
The median time from FDA receipt to decision across Airstrip Technologies, LP's cleared 510(k)s is 76 days.
What devices does Airstrip Technologies, LP make?
Its most frequent FDA product codes are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 9); MSX (System, Network And Communication, Physiological Monitors, 3); HGM (System, Monitoring, Perinatal, 2).
Has Airstrip Technologies, LP had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Airstrip Technologies, LP; the most recent began 2016-08-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Airstrip Technologies, LP clearances with predicates and recalls
- Run predicate analysis for product code MWI, Airstrip Technologies, LP's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.