Panpac Medical Corporation: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Panpac Medical Corporation” (first 2010, latest 2018), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 275 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 | 1 | 185 |
| 2014 | 2 | 321 |
| 2015 | 0 | — |
| 2016 | 1 | 232 |
| 2017 | 1 | 269 |
| 2018 | 1 | 371 |
| 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, 510(k)s cleared under the name Panpac Medical Corporation took a median 320 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HHW | Pessary, Vaginal | 4 | 4 |
| LKF | Cannula, Manipulator/Injector, Uterine | 4 | 4 |
| HDX | Dilator, Vaginal | 1 | 1 |
| HGH | Cannula, Suction, Uterine | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
Review panels
Most recent Panpac Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173351 | Panpac Flexi Shelf Pessary | HHW | 2018-10-31 | 371 |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | HGH | 2017-01-13 | 269 |
| K153422 | Panpac Disposable Pessary Fitting Set | HHW | 2016-07-14 | 232 |
| K132670 | PANPAC INFLATABLE DOCUT PESSARY | HHW | 2014-06-04 | 281 |
| K130087 | PANPAC WORD/BARTHOLIN CATHETER | KNA | 2014-01-10 | 361 |
| K130273 | PANPAC VAGINAL DILATORS | HDX | 2013-08-08 | 185 |
| K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE | LKF | 2011-12-15 | 441 |
| K092982 | THE PANPAC SUCTION CURETTE | HHK | 2010-07-26 | 301 |
| K092981 | PANPAC VAGINAL PESSARY | HHW | 2010-07-22 | 297 |
| K092983 | PANPAC HSG CATHETER SET | LKF | 2010-06-07 | 252 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Panpac Medical Corporation.
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 Panpac Medical Corporation?
FDA lists 12 510(k) clearances under the applicant name “Panpac Medical Corporation” (first 2010, latest 2018), across 6 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 Panpac Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Panpac Medical Corporation is 275 days.
Which FDA product codes appear under Panpac Medical Corporation?
The most frequent FDA product codes under this applicant name are HHW (Pessary, Vaginal, 4); LKF (Cannula, Manipulator/Injector, Uterine, 4); HDX (Dilator, Vaginal, 1).
Next steps
- See all 12 Panpac Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code HHW, Panpac Medical Corporation'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.