Cleared Traditional

K012935 - THECURVE, ITEM 507

K012935 is an FDA 510(k) clearance for THECURVE, manufactured by Select Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K012935 · Select Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
41d
Days
Class 2
Risk

K012935 is an FDA 510(k) clearance for the THECURVE, ITEM 507. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on October 11, 2001 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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 Select Medical Systems, Inc. devices

FDA 510(k) Submission Details - K012935

510(k) Number K012935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date October 11, 2001
Days to Decision 41 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
119d faster than avg
Panel avg: 160d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - MFD Cannula, Intrauterine Insemination

All 20
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K012935.
`THE INSEMINATOR' (PROPOSED)
K984306 · Wallach Surgical Devices, Inc. · Mar 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · Medworks Corp. · Jan 1999
MEDWORKS INSEMINATION CATHETER
K982628 · Medworks Corp. · Aug 1998
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
K980061 · Rocket Medical Plc · Mar 1998
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · A & A Medical, Inc. · Oct 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · A & A Medical, Inc. · Aug 1997