510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932188Substantially Equivalent

Safeset Reservoir

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932188 is the FDA 510(k) clearance record for SAFESET RESERVOIR, a class II device, cleared for Abbott Laboratories on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 16 recalls naming K932188.

Clearance record

Decision date
Received
(172 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20262
October 20260