Cleared Traditional

DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (K092827) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092827 · Dimeda Instrumente GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
116d
Days
Class 2
Risk

K092827 is an FDA 510(k) clearance for the DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX. Classified as Forceps, Obstetrical (product code HDA), Class II - Special Controls.

Submitted by Dimeda Instrumente GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on January 8, 2010 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4400 - 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 Dimeda Instrumente GmbH devices

Submission Details

510(k) Number K092827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date January 08, 2010
Days to Decision 116 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
44d faster than avg
Panel avg: 160d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDA Forceps, Obstetrical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4400
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.