Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifecare Services, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
192 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913423 | LIFECARE REMOTE ALARM II | Lifecare Services, Inc. | 1992-01-30 | 192 | 0 |
| K912224 | LIFECARE CPAP-100 | Lifecare Services, Inc. | 1991-09-23 | 126 | 0 |
| K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR | Lifecare Services, Inc. | 1991-06-03 | 89 | 0 |
| K894779 | LIFECARE NASAL MASK KIT CAT. NO. 06-800 | Lifecare Services, Inc. | 1990-01-12 | 169 | 0 |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | Lifecare Services, Inc. | 1989-11-21 | 67 | 0 |
| K894361 | LIFECARE PRESSURE ALARM CAT. NO. 34-010 | Lifecare Services, Inc. | 1989-10-05 | 83 | 0 |
| K880378 | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 | Lifecare Services, Inc. | 1988-09-30 | 247 | 0 |
| K873570 | LIFECARE EXHALATION VALVE #06-699 | Lifecare Services, Inc. | 1987-11-30 | 89 | 0 |
| K862212 | LIFECARE REMOTE ALARM #34-001 | Lifecare Services, Inc. | 1986-06-23 | 13 | 0 |
| K842876 | PORTABLE LIFECARE VENTILATOR PLV-102 | Lifecare Services, Inc. | 1984-08-29 | 37 | 9 |
| K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 | Lifecare Services, Inc. | 1983-10-20 | 79 | 2 |
| K802914 | 6-435 FILTER PAD, 5/PKG. | Lifecare Services, Inc. | 1980-12-19 | 31 | 0 |
| K802925 | 6-415 FILTER, ELEMENT, 170-C | Lifecare Services, Inc. | 1980-12-19 | 30 | 0 |
| K801859 | CAM-10 RESPIRATORY HOSE ASSEMBLIES | Lifecare Services, Inc. | 1980-09-09 | 35 | 0 |
| K800999 | CAM-10 EXSUFFLATION BELT #11-001 | Lifecare Services, Inc. | 1980-05-28 | 33 | 0 |
| K792673 | CAM-10 CUIRASS SHELL | Lifecare Services, Inc. | 1980-01-11 | 15 | 0 |
| K791406 | CAM-10 CHEST SHELL | Lifecare Services, Inc. | 1979-08-10 | 10 | 0 |
| K791188 | CAM-10 BATTERY PACK (#7-001) | Lifecare Services, Inc. | 1979-07-05 | 9 | 0 |
| K791033 | CAM-10 PVV PORTABLE VOLUME VENTILATOR | Lifecare Services, Inc. | 1979-07-03 | 28 | 0 |
| K790605 | RESPIRAOTR, CAM-10 RBL | Lifecare Services, Inc. | 1979-07-03 | 96 | 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