Cleared Traditional

K942207 - REFLEX INS INSUFFLATION NEEDLE

K942207 is an FDA 510(k) clearance for REFLEX INS INSUFFLATION NEEDLE, manufactured by Richard-Allan Medical. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K942207 · Richard-Allan Medical · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
22d
Days
Class 2
Risk

K942207 is an FDA 510(k) clearance for the REFLEX INS INSUFFLATION NEEDLE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 22 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard-Allan Medical devices

FDA 510(k) Submission Details - K942207

510(k) Number K942207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1994
Decision Date May 27, 1994
Days to Decision 22 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 160d · This submission: 22d
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 133
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K942207.
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · Deroyal Industries, Inc. · Feb 1995
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
K943954 · Conmedcorp · Nov 1994
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
K935862 · Northgate Technologies, Inc. · Aug 1994
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
K934926 · Andronic Devices, Ltd. · May 1994
INSITE FILTER & TUBING SET
K934928 · Andronic Devices, Ltd. · May 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994