510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013976Substantially Equivalent

Boehringer MRI Suction Regulatory

Boehringer Laboratories, LLC, Norristown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013976 is the FDA 510(k) clearance record for BOEHRINGER MRI SUCTION REGULATORY, a class II device, cleared for Boehringer Laboratories on under FDA product code KDP (Regulator, Vacuum). FDA records list 44 510(k) clearances for Boehringer Laboratories, from to . As of , FDA records show no recalls naming K013976.

Clearance record

Decision date
Received
(36 days to decision)
Product code
KDP Regulator, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Boehringer Laboratories 500 E. Washington St., Norristown PA
510(k) summary
Statement
Third party review
No

Clearances, product code KDP

Trailing 12 months

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

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