510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831568Substantially Equivalent

Reliance Tempo Ophth. Instr Stand

F. & F. Koenigkramer, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831568 is the FDA 510(k) clearance record for RELIANCE TEMPO OPHTH. INSTR STAND, a class I device, cleared for F. & F. Koenigkramer on under FDA product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type). FDA records list 9 510(k) clearances for F. & F. Koenigkramer, from to . As of , FDA records show no recalls naming K831568.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
F. & F. Koenigkramer 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HHF

Trailing 12 months

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

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