Pressure Products Medical Device Manufacturing, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pressure Products Medical Device Manufacturing, LLC” (first 2017, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 105 days. Since 2017 the median was 105 days, against 64 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 2 | 159 |
| 2018 | 3 | 148 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 29 |
| 2022 | 1 | 93 |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 1 | 105 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pressure Products Medical Device Manufacturing, LLC took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 64 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRC | Trocar | 7 | 7 |
| DXF | Catheter, Septostomy | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Pressure Products Medical Device Manufacturing, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | DXF | 2026-03-13 | 105 |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | DRC | 2024-05-17 | 30 |
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | DRC | 2022-09-14 | 93 |
| K210328 | SafeSept Blunt Needle | DRC | 2021-03-05 | 29 |
| K181031 | TSI Transseptal Introducer | DYB | 2018-10-26 | 191 |
| K172950 | TSN Transseptal Needle | DRC | 2018-02-21 | 148 |
| K172934 | Needle Free Transseptal Cannula | DRC | 2018-02-16 | 144 |
| K172893 | SafeSept Needle Free Transseptal Guidewire | DRC | 2017-12-21 | 90 |
| K170671 | SafeSept Transseptal Guidewire | DRC | 2017-10-20 | 228 |
Recalls
openFDA lists no recalls under a recalling firm named Pressure Products Medical Device Manufacturing, LLC.
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.
- Pressure Point, Inc. (1 510(k)s)
- Pressure Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pressure Products Medical Device Manufacturing, LLC?
FDA lists 9 510(k) clearances under the applicant name “Pressure Products Medical Device Manufacturing, LLC” (first 2017, latest 2026), across 3 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 Pressure Products Medical Device Manufacturing, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pressure Products Medical Device Manufacturing, LLC is 105 days. Since 2017: 105 days, versus 64 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pressure Products Medical Device Manufacturing, LLC?
The most frequent FDA product codes under this applicant name are DRC (Trocar, 7); DXF (Catheter, Septostomy, 1); DYB (Introducer, Catheter, 1).
Next steps
- See all 9 Pressure Products Medical Device Manufacturing, LLC clearances with predicates and recalls
- Run predicate analysis for product code DRC, Pressure Products Medical Device Manufacturing, LLC'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.