Precision Cap Systems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Precision Cap Systems” (first 1983, latest 1983), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 7 | 7 |
Review panels
- Neurology (7)
Most recent Precision Cap Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830602 | PRECISION CAP STRAPS | GXY | 1983-03-24 | 28 |
| K830601 | FOAMIES DIAPOS. FOAM RUBBER PADS | GXY | 1983-03-24 | 28 |
| K830600 | REFERENCE & MONITORING ELECTRODE | GXY | 1983-03-24 | 28 |
| K830599 | LOCALIZING ELECTRODE | GXY | 1983-03-24 | 28 |
| K830598 | EVOKED POTENTIAL CAP W/EVOKED POTENTIAL | GXY | 1983-03-24 | 28 |
| K830597 | BABY CAP, ELECTRODE SET & BOARD ADAPTOR | GXY | 1983-03-24 | 28 |
| K830521 | PRECISION EEG CAP W/ELECTRODE SET AND | GXY | 1983-03-24 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Precision Cap Systems.
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.
- Precision Medical, Inc. (30 510(k)s)
- Precision Dynamics Corp. (26 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologicals, Inc. (20 510(k)s)
- Precision Biologic (17 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Acoustics Ind., Inc. (9 510(k)s)
- Precision Vascular Systems, Inc. (7 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
- Precision Therapy Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Cap Systems?
FDA lists 7 510(k) clearances under the applicant name “Precision Cap Systems” (first 1983, latest 1983), across 1 product code 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 Precision Cap Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Cap Systems is 28 days.
Which FDA product codes appear under Precision Cap Systems?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 7).
Next steps
- See all 7 Precision Cap Systems clearances with predicates and recalls
- Run predicate analysis for product code GXY, Precision Cap Systems'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.