510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K203135Substantially Equivalent

Medline Vacu-line Suction Aspirator

MEDLINE INDUSTRIES, LP - Northfield, Northfiled IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203135 is the FDA 510(k) clearance record for Medline Vacu-line Suction Aspirator, a class II device, cleared for Medline Industries, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K203135.

Clearance record

Decision date
Received
(197 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medline Industries, Inc. Three Lake Dr., Northfiled IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTA

Trailing 12 months
6 clearances under product code BTA in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20260