Aequitron Medical, Inc.: FDA clearances and approvals
Aequitron Medical, Inc. has 24 FDA 510(k) clearances (first 1984, latest 1997), across 10 product codes in 5 review panels. Median 510(k) review time: 122 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 9 | 9 |
| CBK | Ventilator, Continuous, Facility Use | 4 | 4 |
| DSH | Recorder, Magnetic Tape, Medical | 3 | 3 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DZD | Tube, Orthodontic | 1 | 1 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
- Anesthesiology (15)
- Cardiovascular (5)
- Obstetrics and Gynecology (2)
- Dental (1)
- General Hospital (1)
Most recent Aequitron Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | BZQ | 1997-04-18 | 333 |
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | CBK | 1996-06-20 | 364 |
| K944654 | OXYGEN CONCENTRATION INDICATOR | CCL | 1994-11-08 | 48 |
| K914424 | MODEL 6213 REMOTE ALARM | CBK | 1992-09-10 | 343 |
| K915381 | PORTABLE OXYGEN GENERATOR | CAW | 1992-03-11 | 103 |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | DZD | 1991-09-19 | 174 |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | BZQ | 1991-04-10 | 273 |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | CBK | 1990-11-30 | 10 |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | CBK | 1990-11-30 | 142 |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | BZQ | 1990-07-13 | 17 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aequitron Medical, Inc..
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 Aequitron Medical, Inc. have?
Aequitron Medical, Inc. has 24 FDA 510(k) clearances (first 1984, latest 1997), across 10 product codes in 5 review panels.
How long does FDA take to clear Aequitron Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aequitron Medical, Inc.'s cleared 510(k)s is 122 days.
What devices does Aequitron Medical, Inc. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 9); CBK (Ventilator, Continuous, Facility Use, 4); DSH (Recorder, Magnetic Tape, Medical, 3).
Has Aequitron Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aequitron Medical, Inc. Related entities may recall under other names.
Next steps
- See all 24 Aequitron Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Aequitron Medical, Inc.'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.