Selfcare, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Selfcare, Inc.” (first 1996, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 9 | 9 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 1 |
Review panels
- Clinical Chemistry (15)
Most recent Selfcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | CEP | 2000-10-12 | 29 |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2000-08-07 | 24 |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | LCX | 2000-07-27 | 24 |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2000-06-02 | 28 |
| K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2000-03-17 | 24 |
| K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | 1999-11-12 | 16 |
| K991480 | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | CGA | 1999-09-17 | 142 |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | CEP | 1999-05-25 | 28 |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | CEP | 1999-05-25 | 34 |
| K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | 1999-04-20 | 29 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Selfcare, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Selfcare, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Selfcare, Inc.” (first 1996, latest 2000), across 4 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 Selfcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Selfcare, Inc. is 29 days.
Which FDA product codes appear under Selfcare, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 9); CEP (Radioimmunoassay, Luteinizing Hormone, 3); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2).
Next steps
- See all 15 Selfcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Selfcare, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.