Procedure Products, Inc.: FDA clearances and approvals
Procedure Products, Inc. has 16 FDA 510(k) clearances (first 1981, latest 2017), across 10 product codes in 3 review panels. Median 510(k) review time: 76 days. openFDA lists 1 product recall by a recalling firm named Procedure Products, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 269 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Procedure Products, Inc.'s cleared 510(k)s took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
Most recent Procedure Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161812 | Freedom Syringe | FMF | 2017-03-27 | 269 |
| K923194 | INSUFFLATOR CONNECTING FILTER | HIF | 1993-10-08 | 465 |
| K922536 | TORQUE DEVICE | DQX | 1992-12-10 | 196 |
| K914128 | CONNECTING SET | DQO | 1991-11-27 | 75 |
| K910673 | BAG SPIGOT | KPE | 1991-04-24 | 68 |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | FMF | 1988-12-20 | 19 |
| K874747 | 10CC SYRINGE CONTROL RING SET | FMF | 1988-02-04 | 78 |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | DQO | 1988-01-29 | 116 |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | DTL | 1986-01-13 | 126 |
| K842173 | DISPOSABLE STOPCOCKS | FMG | 1984-09-05 | 113 |
6 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-10-27.
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 Procedure Products, Inc. have?
Procedure Products, Inc. has 16 FDA 510(k) clearances (first 1981, latest 2017), across 10 product codes in 3 review panels.
How long does FDA take to clear Procedure Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Procedure Products, Inc.'s cleared 510(k)s is 76 days.
What devices does Procedure Products, Inc. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 4); DQO (Catheter, Intravascular, Diagnostic, 3); FPA (Set, Administration, Intravascular, 2).
Has Procedure Products, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Procedure Products, Inc; the most recent began 2015-10-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Procedure Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Procedure Products, Inc.'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.