510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811424Substantially Equivalent

Electronic Apgar Timer

Pt&E, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811424 is the FDA 510(k) clearance record for ELECTRONIC APGAR TIMER, a class I device, cleared for Pt&E on under FDA product code LHB (Timer, Apgar). FDA records list one 510(k) clearance for Pt&E. As of , FDA records show no recalls naming K811424.

Clearance record

Decision date
Received
(48 days to decision)
Product code
LHB Timer, Apgar
Regulation
21 CFR 880.2930
Device class
Class I
Review panel
General Hospital
Applicant
Pt&E 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHB

Trailing 12 months

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

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