510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963136Substantially Equivalent

Pacer Model 100 Infusion Controller

Health Watch, Inc., South West Ranches FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963136 is the FDA 510(k) clearance record for PACER MODEL 100 INFUSION CONTROLLER, a class II device, cleared for Health Watch, Inc. on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list 2 510(k) clearances for Health Watch, Inc., from to . As of , FDA records show no recalls naming K963136.

Clearance record

Decision date
Received
(423 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Health Watch, Inc. 20310 SW 48th St., South West Ranches FL
510(k) summary
Statement
Third party review
No

Clearances, product code LDR

Trailing 12 months

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

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