510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K081587Substantially Equivalent

Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530

Krell Precision (Yang Zhou) Co., Ltd., Flintville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081587 is the FDA 510(k) clearance record for KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530, a class II device, cleared for Krell Precision (Yang Zhou) Co., Ltd. on under FDA product code MNW (Analyzer, Body Composition). FDA records list one 510(k) clearance for Krell Precision (Yang Zhou) Co., Ltd. As of , FDA records show no recalls naming K081587.

Clearance record

Decision date
Received
(141 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Krell Precision (Yang Zhou) Co., Ltd. 340 Shady Grove Rd., Flintville TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNW

Trailing 12 months

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

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