510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920629Substantially Equivalent

Quinevac II

Recto Molded Products, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920629 is the FDA 510(k) clearance record for QUINEVAC II, a class II device, cleared for Recto Molded Products, Inc. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 2 510(k) clearances for Recto Molded Products, Inc., from to . As of , FDA records show no recalls naming K920629.

Clearance record

Decision date
Received
(406 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Recto Molded Products, Inc. 700 Thirteenth St. NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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