510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862647Substantially Equivalent

Physiological Monitor, Models 401,402 & 403

Ivy Biomedical Systems, Inc., Branford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862647 is the FDA 510(k) clearance record for PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403, a class II device, cleared for Ivy Biomedical Systems, Inc. on under FDA product code DSK (Computer, Blood-Pressure). FDA records list 27 510(k) clearances for Ivy Biomedical Systems, Inc., from to . As of , FDA records show no recalls naming K862647.

Clearance record

Decision date
Received
(38 days to decision)
Product code
DSK Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Applicant
Ivy Biomedical Systems, Inc. 11 Business Park Dr., Branford CT
Third party review
No

Clearances, product code DSK

Trailing 12 months

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

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