510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192385Substantially Equivalent

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

Ivwatch, LLC, Newport News VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192385 is the FDA 510(k) clearance record for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable, a class II device, cleared for Ivwatch, LLC on under FDA product code PMS (Peripheral Intravenous (Piv) Infiltration Monitor). FDA's definition for product code PMS reads: "Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations". FDA records list 6 510(k) clearances for Ivwatch, LLC, from to . As of , FDA records show no recalls naming K192385.

Clearance record

Decision date
Received
(303 days to decision)
Product code
PMS Peripheral Intravenous (Piv) Infiltration Monitor
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Ivwatch, LLC 630 Hofstadter Rd., Suite 300, Newport News VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMS

Trailing 12 months

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

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