Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthdyne Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
252 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983572 | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 | Healthdyne Technologies, Inc. | 1999-03-19 | 157 | 0 |
| K974453 | NASAL INTERFACE MODEL 7910 | Healthdyne Technologies, Inc. | 1998-08-04 | 252 | 0 |
| K974879 | MODEL 7410 VOYAGER | Healthdyne Technologies, Inc. | 1998-06-29 | 181 | 0 |
| K972614 | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCEN | Healthdyne Technologies, Inc. | 1998-01-20 | 190 | 0 |
| K971867 | ALICE 4R SYSTEM | Healthdyne Technologies, Inc. | 1997-08-13 | 85 | 0 |
| K971545 | PROTEGE LIQUID OXYGEN SYSTEM | Healthdyne Technologies, Inc. | 1997-07-25 | 88 | 0 |
| K970173 | MODEL 1700 TRANQUILITY BILEVEL SYSTEM | Healthdyne Technologies, Inc. | 1997-04-16 | 90 | 1 |
| K962517 | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV | Healthdyne Technologies, Inc. | 1997-02-20 | 238 | 0 |
| K943509 | 7300 NASAL CPAP SYSTEM | Healthdyne Technologies, Inc. | 1994-08-05 | 16 | 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