Cleared Special

K020954 - H/S PROCEDURE TRAY (5F)

K020954 is an FDA 510(k) clearance for H/S PROCEDURE TRAY (5F), manufactured by Ackrad Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Special 510(k) pathway after a 30-day FDA review.

K020954 · Ackrad Laboratories · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
30d
Days
Class 2
Risk

K020954 is an FDA 510(k) clearance for the H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE.... Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on April 24, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ackrad Laboratories devices

FDA 510(k) Submission Details - K020954

510(k) Number K020954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date April 24, 2002
Days to Decision 30 days
Submission Type Special
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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LKF Device Classification - Class 2, Special Controls

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - LKF Cannula, Manipulator/injector, Uterine

All 46
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K020954.
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · Irvine Scientific Sales Co., Inc. · Oct 2006
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004
SIB CATHETER, MODEL 61-7005
K021272 · Ackrad Laboratories · May 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · Ackrad Laboratories · Apr 2002
SF SH CATHETER, MODEL R65-945
K013437 · A & A Medical, Inc. · Nov 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · A & A Medical, Inc. · Nov 2001