510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851415Substantially Equivalent

Body Analysis System (Deemed Se 87/09/18)

Medi-Sport Testing, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851415 is the FDA 510(k) clearance record for BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18), a class II device, cleared for Medi-Sport Testing, Inc. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list one 510(k) clearance for Medi-Sport Testing, Inc. As of , FDA records show no recalls naming K851415.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Medi-Sport Testing, Inc. 11919 NE Glisan, Portland OR
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260