Cleared Traditional

K905549 - THE DART

K905549 is an FDA 510(k) clearance for THE DART, manufactured by Dexide, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K905549 · Dexide, Inc. · Obstetrics & Gynecology device
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Feb 1991
Decision
70d
Days
Class 2
Risk

K905549 is an FDA 510(k) clearance for the THE DART. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 70 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.

FDA 510(k) Submission Details - K905549

510(k) Number K905549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date February 19, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 161d · This submission: 70d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K905549.
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · Northgate Technologies, Inc. · Mar 1991
LAPAROFLATOR ELECTRONIC 3509
K910883 · F.M. Wiest USA, Inc. · Mar 1991
LAP 3501 HIGH FLOW INSUFFLATOR
K905705 · Circon Acmi · Feb 1991
ELMED PNEUMOMAT DIGITAL
K905417 · Elmed, Inc. · Jan 1991
RAPID AUTOMATIC PNEUMOPERITONEUM-I
K900808 · Trek Medical Products, Inc. · Sep 1990
OTT INSUFFLATION FILTER TUBING
K900878 · Gynescope Corp. · May 1990
K905549 · THE DART
Download PDF Dexide, Inc.