Healthdyne, Inc.: FDA clearances and approvals
Healthdyne, Inc. has 35 FDA 510(k) clearances (first 1978, latest 1995), across 18 product codes in 6 review panels. Median 510(k) review time: 43 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 | 8 | 8 |
| CBK | Ventilator, Continuous, Facility Use | 6 | 6 |
| CAW | Generator, Oxygen, Portable | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
Plus 8 more product codes.
Review panels
- Anesthesiology (27)
- Cardiovascular (3)
- Clinical Chemistry (2)
- General Hospital (1)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Healthdyne, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | BZD | 1995-09-21 | 237 |
| K922106 | ALICE | OLV | 1994-07-06 | 792 |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | CAW | 1994-05-27 | 10 |
| K934502 | FLOW SPIROMETER | BZH | 1994-04-04 | 202 |
| K924146 | OH-500 OXYGEN CONCENTRATOR | CAW | 1993-01-07 | 142 |
| K922623 | NEBULIZER SYSTEM | BTI | 1992-12-01 | 182 |
| K910118 | DATA RECORDER | FLL | 1991-02-14 | 34 |
| K903287 | MODEL 900S APNEA/HEART MONITOR | BZQ | 1990-08-17 | 37 |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | HFM | 1990-01-22 | 230 |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | DRT | 1989-05-23 | 56 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Healthdyne, 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 Healthdyne, Inc. have?
Healthdyne, Inc. has 35 FDA 510(k) clearances (first 1978, latest 1995), across 18 product codes in 6 review panels.
How long does FDA take to clear Healthdyne, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Healthdyne, Inc.'s cleared 510(k)s is 43 days.
What devices does Healthdyne, Inc. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 8); CBK (Ventilator, Continuous, Facility Use, 6); CAW (Generator, Oxygen, Portable, 5).
Has Healthdyne, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Healthdyne, Inc. Related entities may recall under other names.
Next steps
- See all 35 Healthdyne, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Healthdyne, 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.