Precision Med Products, Ltd.: FDA clearances and approvals
Precision Med Products, Ltd. has 16 FDA 510(k) clearances (first 1993, latest 1993), across 6 product codes in 1 review panel. Median 510(k) review time: 50 days.
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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 10 | 10 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Review panels
- Anesthesiology (16)
Most recent Precision Med Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932711 | PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS | BTR | 1993-07-23 | 49 |
| K932710 | GAS SAMPLING LINES AND CONNECTORS | CAI | 1993-07-23 | 49 |
| K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | BZR | 1993-07-23 | 49 |
| K932708 | PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS | CAI | 1993-07-23 | 49 |
| K932707 | ADULT ANESTHESIA BREATHING CIRCUIT | CAI | 1993-07-23 | 49 |
| K932706 | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | BZO | 1993-07-23 | 49 |
| K932712 | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | BZO | 1993-07-22 | 48 |
| K932497 | PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING | CAI | 1993-07-22 | 59 |
| K932489 | PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. | CAI | 1993-07-22 | 59 |
| K932488 | PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS | CAI | 1993-07-22 | 59 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Precision Med Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Precision Med Products, Ltd. have?
Precision Med Products, Ltd. has 16 FDA 510(k) clearances (first 1993, latest 1993), across 6 product codes in 1 review panel.
How long does FDA take to clear Precision Med Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Precision Med Products, Ltd.'s cleared 510(k)s is 50 days.
What devices does Precision Med Products, Ltd. make?
Its most frequent FDA product codes are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 10); BZO (Set, Tubing And Support, Ventilator (W Harness), 2); BTC (Bag, Reservoir, 1).
Has Precision Med Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Precision Med Products, Ltd. Related entities may recall under other names.
Next steps
- See all 16 Precision Med Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Precision Med Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.