510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K230319Unknown

Passio Pump Drainage System

Bearpac Medical, LLC, Moultonborough NH / Traditional, Unknown
FDA source (opens on fda.gov)

K230319 is the FDA 510(k) clearance record for Passio Pump Drainage System, a class II device, cleared for Bearpac Medical on under FDA product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling). FDA's definition for product code PNG reads: "For drainage of refractory ascites with long-term occurrence from the peritoneal cavity". FDA records list 3 510(k) clearances for Bearpac Medical, from to . As of , FDA records show no recalls naming K230319.

Clearance record

Decision date
Received
(291 days to decision)
Product code
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bearpac Medical 124 W. Pt. Rd., Moultonborough NH
510(k) summary
Statement
Third party review
No

Clearances, product code PNG

Trailing 12 months

FDA records hold no clearances under product code PNG in the trailing twelve months.

FDA records show no clearances under product code PNG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260