Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Pressure Products Medical Device Manufacturing, LLC · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

105 daysmedian FDA review time
228 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF23Pressure Products Medical Device Manufacturing, LLC2026-03-131050
K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, Pressure Products Medical Device Manufacturing, LLC2024-05-17300
K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC2022-09-14930
K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC2021-03-05290
K181031TSI Transseptal IntroducerPressure Products Medical Device Manufacturing, LLC2018-10-261911
K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC2018-02-211480
K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC2018-02-161440
K172893SafeSept Needle Free Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-12-21900
K170671SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-10-202280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda