Cleared Traditional

K924481 - INSUFFLATION TUBING

K924481 is an FDA 510(k) clearance for INSUFFLATION TUBING, manufactured by Applied Medical Resources. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 565-day FDA review.

K924481 · Applied Medical Resources · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
565d
Days
Class 2
Risk

K924481 is an FDA 510(k) clearance for the INSUFFLATION TUBING. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 565 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Applied Medical Resources devices

FDA 510(k) Submission Details - K924481

510(k) Number K924481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1992
Decision Date March 22, 1994
Days to Decision 565 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
405d slower than avg
Panel avg: 160d · This submission: 565d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 92
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K924481.
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934114 · KARL STORZ Endoscopy-America, Inc. · May 1994
ELECTRONIC INSUFFLATOR MODEL 2054.61
K921756 · Richard Wolf Medical Instruments Corp. · Mar 1994
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
K934131 · Deroyal Industries, Inc. · Mar 1994
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
K935503 · Davol, Inc. · Mar 1994
INFILTUBE
K925558 · Medsurg Industries, Inc. · Mar 1994