510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831319Substantially Equivalent

Patient Monitor #404

Analogic Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831319 is the FDA 510(k) clearance record for PATIENT MONITOR #404, a class II device, cleared for Analogic Corp. on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 39 510(k) clearances for Analogic Corp., from to . As of , FDA records show no recalls naming K831319.

Clearance record

Decision date
Received
(335 days to decision)
Product code
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Analogic Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KLK

Trailing 12 months

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

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