Cleared Traditional

K842231 - ACKRAD HYSTEROSALPINGOGRAPHY SET

K842231 is an FDA 510(k) clearance for ACKRAD HYSTEROSALPINGOGRAPHY SET, manufactured by Ackrad Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K842231 · Ackrad Laboratories · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
106d
Days
Class 2
Risk

K842231 is an FDA 510(k) clearance for the ACKRAD HYSTEROSALPINGOGRAPHY SET. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Ackrad Laboratories (Walker, US). The FDA issued a Cleared decision on September 19, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ackrad Laboratories devices

FDA 510(k) Submission Details - K842231

510(k) Number K842231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date September 19, 1984
Days to Decision 106 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
54d faster than avg
Panel avg: 160d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 30
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K842231.
COOK HYSTEROCATH(TM)
K884291 · Cook, Inc. · Dec 1988
INTRAUTERINE HEMOSTASIS BALLOON STENT
K863439 · Mentor Corp. · Jun 1987
MODIFIED HYSTEROSALPINGOGRAPY SET
K871069 · Ackrad Laboratories · Apr 1987
FALLOPIAN TUBE FORCEPS
K810483 · American V. Mueller · Mar 1981
OVARY FORCEPS
K810484 · American V. Mueller · Mar 1981
STERILIZATION PROCESS/DBL. GRIP CORD CLP
K792631 · Procter & Gamble Mfg. Co. · Jan 1980