510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942747Substantially Equivalent

Malcolm-Lynn(tm) Eot Suction Reg Valve(tm) (Srv) )

Engineered Orthopedic Technologies, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942747 is the FDA 510(k) clearance record for MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ), a class II device, cleared for Engineered Orthopedic Technologies, Inc. on under FDA product code KDP (Regulator, Vacuum). FDA records list 2 510(k) clearances for Engineered Orthopedic Technologies, Inc., from to . As of , FDA records show no recalls naming K942747.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KDP Regulator, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Engineered Orthopedic Technologies, Inc. 920-C Calle Negocio, San Clemente CA
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