Cleared Traditional

K862931 - MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358

K862931 is an FDA 510(k) clearance for MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358, manufactured by Global Medical Prods, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNC cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K862931 · Global Medical Prods, Inc. · Obstetrics & Gynecology device
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Aug 1986
Decision
3d
Days
Class 2
Risk

K862931 is an FDA 510(k) clearance for the MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358. Classified as Table, Obstetric (and Accessories) (product code KNC), Class II - Special Controls.

Submitted by Global Medical Prods, Inc. (Chicago, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4900 - 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.

FDA 510(k) Submission Details - K862931

510(k) Number K862931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1986
Decision Date August 07, 1986
Days to Decision 3 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
158d faster than avg
Panel avg: 161d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNC Device Classification - Class 2, Special Controls

Product Code KNC Table, Obstetric (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4900
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 - KNC Table, Obstetric (and Accessories)

All 11
Devices cleared under the same product code (KNC) and FDA review panel - the closest regulatory comparables to K862931.
OBSTETRICAL SAFETY SYSTEM
K884868 · Buckman Co., Inc. · Mar 1989
STRYKER MODEL 977 BIRTHING BED
K870745 · Stryker Corp. · Feb 1987
PALMER OBSTETRIC BRACE
K864194 · Ad-Tech Medical Instrument Corp · Jan 1987
LABOR-DELIVERY STRETCH/BED
K861030 · Adel Medical , Ltd. · Apr 1986
DELIVERY 4 TABLE
K831309 · Amsco Co. · Jun 1983
K862931 · MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358
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