Healthdyne Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Healthdyne Technologies, Inc.” (first 1994, latest 1999), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 157 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 4 | 4 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Anesthesiology (8)
- Neurology (1)
Most recent Healthdyne Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983572 | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 | MNR | 1999-03-19 | 157 |
| K974453 | NASAL INTERFACE MODEL 7910 | BZD | 1998-08-04 | 252 |
| K974879 | MODEL 7410 VOYAGER | BZD | 1998-06-29 | 181 |
| K972614 | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 | CAW | 1998-01-20 | 190 |
| K971867 | ALICE 4R SYSTEM | OLV | 1997-08-13 | 85 |
| K971545 | PROTEGE LIQUID OXYGEN SYSTEM | BYJ | 1997-07-25 | 88 |
| K970173 | MODEL 1700 TRANQUILITY BILEVEL SYSTEM | BZD | 1997-04-16 | 90 |
| K962517 | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV | MNS | 1997-02-20 | 238 |
| K943509 | 7300 NASAL CPAP SYSTEM | BZD | 1994-08-05 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Healthdyne Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Healthdyne, Inc. (35 510(k)s)
- Healthdyne Cardiovascular, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthdyne Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Healthdyne Technologies, Inc.” (first 1994, latest 1999), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Healthdyne Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthdyne Technologies, Inc. is 157 days.
Which FDA product codes appear under Healthdyne Technologies, Inc.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 4); BYJ (Unit, Liquid-Oxygen, Portable, 1); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 9 Healthdyne Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Healthdyne Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.