510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163139Substantially Equivalent

PleuraFlow System with FlowGlide

Clearflow, Inc, Anaheim CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163139 is the FDA 510(k) clearance record for PleuraFlow System with FlowGlide, a class II device, cleared for Clearflow, Inc. on under FDA product code OTK (Wound Drain Catheter System). FDA's definition for product code OTK reads: "For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures". FDA records list 6 510(k) clearances for Clearflow, Inc., from to . As of , FDA records show no recalls naming K163139.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OTK Wound Drain Catheter System
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Clearflow, Inc. 1630 S. Sunkist St. Suite E, Anaheim CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTK

Trailing 12 months

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

FDA records show no clearances under product code OTK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OTK, 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