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
K040605Substantially Equivalent

Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100

Dymedix, Inc., Stoughton WI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040605 is the FDA 510(k) clearance record for DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100, a class II device, cleared for Dymedix, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 4 510(k) clearances for Dymedix, Inc., from to . As of , FDA records show no recalls naming K040605.

Clearance record

Decision date
Received
(49 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Dymedix, Inc. 800 Levanger Ln., Stoughton WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260