Lifecare Services, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Lifecare Services, Inc.” (first 1979, latest 1992), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 8 | 8 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 3 | 3 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (18)
- Cardiovascular (1)
- General Hospital (1)
Most recent Lifecare Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913423 | LIFECARE REMOTE ALARM II | CBK | 1992-01-30 | 192 |
| K912224 | LIFECARE CPAP-100 | BZD | 1991-09-23 | 126 |
| K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR | BYT | 1991-06-03 | 89 |
| K894779 | LIFECARE NASAL MASK KIT CAT. NO. 06-800 | BYE | 1990-01-12 | 169 |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | CCQ | 1989-11-21 | 67 |
| K894361 | LIFECARE PRESSURE ALARM CAT. NO. 34-010 | CAP | 1989-10-05 | 83 |
| K880378 | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 | CCL | 1988-09-30 | 247 |
| K873570 | LIFECARE EXHALATION VALVE #06-699 | CBP | 1987-11-30 | 89 |
| K862212 | LIFECARE REMOTE ALARM #34-001 | CBK | 1986-06-23 | 13 |
| K842876 | PORTABLE LIFECARE VENTILATOR PLV-102 | CBK | 1984-08-29 | 37 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lifecare Services, 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.
- Lifecare , Ltd. (3 510(k)s)
- Lifecare Imaging Intl., Ltd. (1 510(k)s)
- Lifecare International,Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lifecare Services, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Lifecare Services, Inc.” (first 1979, latest 1992), across 11 product codes in 3 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 Lifecare Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lifecare Services, Inc. is 52 days.
Which FDA product codes appear under Lifecare Services, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 8); BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass), 3); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1).
Next steps
- See all 20 Lifecare Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Lifecare Services, 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.