Cleared Traditional

K980212 - MITYVAC

K980212 is an FDA 510(k) clearance for MITYVAC, manufactured by Prism Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDB cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K980212 · Prism Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
169d
Days
Class 2
Risk

K980212 is an FDA 510(k) clearance for the MITYVAC. Classified as Extractor, Vacuum, Fetal (product code HDB), Class II - Special Controls.

Submitted by Prism Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 169 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4340 - 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 Prism Technologies, Inc. devices

FDA 510(k) Submission Details - K980212

510(k) Number K980212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1998
Decision Date July 09, 1998
Days to Decision 169 days
Submission Type Traditional
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
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDB Device Classification - Class 2, Special Controls

Product Code HDB Extractor, Vacuum, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4340
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 - HDB Extractor, Vacuum, Fetal

All 13
Devices cleared under the same product code (HDB) and FDA review panel - the closest regulatory comparables to K980212.
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