510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895881Substantially Equivalent

Motionspect

Baltimore Therapeutic Equipment Co., Hanover MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895881 is the FDA 510(k) clearance record for MOTIONSPECT, a class III device, cleared for Baltimore Therapeutic Equipment Co. on under FDA product code LXW (Column, Adsorption, Low Density, Lipoprotein). FDA records list 7 510(k) clearances for Baltimore Therapeutic Equipment Co., from to . As of , FDA records show no recalls naming K895881.

Clearance record

Decision date
Received
(187 days to decision)
Product code
LXW Column, Adsorption, Low Density, Lipoprotein
Device class
Class III
Review panel
Unknown
Applicant
Baltimore Therapeutic Equipment Co. 7455-L New Ridge Rd., Hanover MD
Third party review
No

Clearances, product code LXW

Trailing 12 months

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

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