510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162582Substantially Equivalent

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

Fisher & Paykel Healthcare, Inc., Auckland, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162582 is the FDA 510(k) clearance record for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit, a class II device, cleared for Fisher & Paykel Healthcare on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, from to . As of , FDA records show no recalls naming K162582.

Clearance record

Decision date
Received
(281 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Fisher & Paykel Healthcare 15 Maurice Paykel Pl., E. Tamaki, Auckland, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260