510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K103812Substantially Equivalent

Mitra-Lift

Sciencity Co., Ltd., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103812 is the FDA 510(k) clearance record for MITRA-LIFT, a class II device, cleared for Sciencity Co., Ltd. on under FDA product code KRH (Ring, Annuloplasty). FDA records list one 510(k) clearance for Sciencity Co., Ltd. As of , FDA records show no recalls naming K103812.

Clearance record

Decision date
Received
(140 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Sciencity Co., Ltd. 325 N. Puente St., Unit B, Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRH

Trailing 12 months
2 clearances under product code KRH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260