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
K842213Substantially Equivalent

Vsm R1

Physio Control, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842213 is the FDA 510(k) clearance record for VSM R1, a class II device, cleared for Physio-Control Corp. on under FDA product code DXO (Transducer, Pressure, Catheter Tip). FDA records list 108 510(k) clearances for Physio-Control Corp., from to . As of , FDA records show no recalls naming K842213.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DXO Transducer, Pressure, Catheter Tip
Regulation
21 CFR 870.2870
Device class
Class II
Review panel
Cardiovascular
Applicant
Physio-Control Corp. 11811 Willows Rd., NE, Redmond WA
Third party review
No

Clearances, product code DXO

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