Rescare , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Rescare , Ltd.” (first 1994, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 399 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 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Rescare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952429 | RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM | BZD | 1996-07-02 | 405 |
| K952475 | SULLIVAN NOSE & MOUTH MASK SYSTEM | BZD | 1996-05-28 | 364 |
| K950582 | SULLIVAN PASSOVER HUMIDIFER | BTT | 1995-09-15 | 218 |
| K931884 | SULLIVAN NASAL VPAP SYSTEM | BZD | 1994-06-07 | 418 |
| K930656 | SULLIVAN III NASAL CPAP SYSTEM | BZD | 1994-03-15 | 399 |
Recalls
openFDA lists no recalls under a recalling firm named Rescare , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rescare , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Rescare , Ltd.” (first 1994, latest 1996), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rescare , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rescare , Ltd. is 399 days.
Which FDA product codes appear under Rescare , Ltd.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 4); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 5 Rescare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Rescare , Ltd.'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.