S.L.P. , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “S.L.P. , Ltd.” (first 2004, latest 2020), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 203 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 | 1 | 300 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name S.L.P. , Ltd. took a median 300 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 3 | 3 |
| DQA | Oximeter | 1 | 1 |
| KZM | Device, Muscle Monitoring | 1 | 1 |
Review panels
- Anesthesiology (4)
- Dental (1)
Most recent S.L.P. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191574 | OxSAT 100 | DQA | 2020-04-09 | 300 |
| K112822 | SLEEPSTRIP II | MNR | 2011-12-27 | 90 |
| K080375 | RMX PHYSIOLOGICAL DATA RECORDER | MNR | 2008-09-02 | 203 |
| K042253 | SLEEPSENSE SLEEP SENSORS | MNR | 2004-10-06 | 47 |
| K030869 | BITESTRIP | KZM | 2004-05-14 | 422 |
Recalls
openFDA lists no recalls under a recalling firm named S.L.P. , 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 S.L.P. , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “S.L.P. , Ltd.” (first 2004, latest 2020), across 3 product codes in 2 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 S.L.P. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name S.L.P. , Ltd. is 203 days.
Which FDA product codes appear under S.L.P. , Ltd.?
The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 3); DQA (Oximeter, 1); KZM (Device, Muscle Monitoring, 1).
Next steps
- See all 5 S.L.P. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNR, S.L.P. , 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.