Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthdyne, Inc. · Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
202 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | Healthdyne, Inc. | 1995-09-21 | 237 | 0 |
| K922106 | ALICE | Healthdyne, Inc. | 1994-07-06 | 792 | 1 |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1994-05-27 | 10 | 0 |
| K934502 | FLOW SPIROMETER | Healthdyne, Inc. | 1994-04-04 | 202 | 0 |
| K924146 | OH-500 OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1993-01-07 | 142 | 0 |
| K922623 | NEBULIZER SYSTEM | Healthdyne, Inc. | 1992-12-01 | 182 | 0 |
| K910118 | DATA RECORDER | Healthdyne, Inc. | 1991-02-14 | 34 | 0 |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Healthdyne, Inc. | 1990-08-17 | 37 | 0 |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | 1990-01-22 | 230 | 0 |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | Healthdyne, Inc. | 1989-05-23 | 56 | 0 |
| K890150 | H-3000 OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1989-01-31 | 18 | 0 |
| K881833 | NASAL CPAP SYSTEM | Healthdyne, Inc. | 1988-06-24 | 56 | 0 |
| K875031 | OXYGEN/PULSE MONITOR | Healthdyne, Inc. | 1988-02-12 | 67 | 0 |
| K874814 | HEALTHDYNE RATE METER | Healthdyne, Inc. | 1988-02-11 | 79 | 0 |
| K874695 | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 | Healthdyne, Inc. | 1988-01-29 | 74 | 0 |
| K861484 | INFANT MONITOR | Healthdyne, Inc. | 1986-05-21 | 29 | 0 |
| K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM | Healthdyne, Inc. | 1986-01-30 | 6 | 0 |
| K854374 | OXYGEN CONCENTRATOR, MODEL BX-5000 | Healthdyne, Inc. | 1986-01-03 | 65 | 0 |
| K853300 | HEALTHDYNE IMPLUSE VENTILATOR | Healthdyne, Inc. | 1985-08-15 | 9 | 0 |
| K843546 | INFANT MONITOR 16900 | Healthdyne, Inc. | 1984-10-10 | 30 | 0 |
| K842207 | WAKO B.G. PRETEST STRIPS | Healthdyne, Inc. | 1984-06-26 | 22 | 0 |
| K841818 | IMPULSE VENTILATOR | Healthdyne, Inc. | 1984-06-05 | 35 | 0 |
| K833351 | DEMAND OXYGEN CONTROLLER | Healthdyne, Inc. | 1984-03-19 | 173 | 0 |
| K840345 | IMPULSE VENTILATOR | Healthdyne, Inc. | 1984-02-23 | 28 | 0 |
| K834099 | BLOOD GLUCOSE MONITOR | Healthdyne, Inc. | 1984-02-03 | 67 | 0 |
| K822871 | MODEL BX-3000 OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1982-10-22 | 25 | 0 |
| K821612 | MODEL 16800 TREND RECORDER | Healthdyne, Inc. | 1982-07-14 | 42 | 0 |
| K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR | Healthdyne, Inc. | 1982-07-13 | 42 | 0 |
| K820645 | INFANT MONITOR | Healthdyne, Inc. | 1982-04-15 | 37 | 0 |
| K813254 | JET VENTILATOR | Healthdyne, Inc. | 1982-02-04 | 77 | 0 |
| K810255 | MEAN PRESSURE MONITOR | Healthdyne, Inc. | 1981-02-12 | 13 | 0 |
| K802583 | INFANT VENTILATOR, (RESPIRATOR) PLAN B | Healthdyne, Inc. | 1980-12-18 | 59 | 0 |
| K802205 | ECG/RESPIRATION STIMULATOR | Healthdyne, Inc. | 1980-10-03 | 22 | 0 |
| K781926 | VENTILATOR, INFANT MODEL 100 | Healthdyne, Inc. | 1978-12-21 | 43 | 0 |
| K781530 | TEMPERATURE CONTROLLER MODEL 17000 | Healthdyne, Inc. | 1978-11-14 | 69 | 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