Cleared Traditional

K831998 - BIRTHWELL BIRTHING SYSTEM

K831998 is an FDA 510(k) clearance for BIRTHWELL BIRTHING SYSTEM, manufactured by Qulab Co.. The device is a Class 2 Obstetrics & Gynecology device with product code KNC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K831998 · Qulab Co. · Obstetrics & Gynecology device
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Sep 1983
Decision
83d
Days
Class 2
Risk

K831998 is an FDA 510(k) clearance for the BIRTHWELL BIRTHING SYSTEM. Classified as Table, Obstetric (and Accessories) (product code KNC), Class II - Special Controls.

Submitted by Qulab Co. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 83 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 - K831998

510(k) Number K831998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date September 12, 1983
Days to Decision 83 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
78d faster than avg
Panel avg: 161d · This submission: 83d
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 21
Devices cleared under the same product code (KNC) and FDA review panel - the closest regulatory comparables to K831998.
PALMER OBSTETIC BRACE
K844183 · Mic Medical Corp. · Feb 1985
LORRAINE DSL LABOR & DELIVERY BED
K842962 · Pulley-Kellam Co., Inc. · Sep 1984
LABOR/DELIVERY/RECOVERY BED LDR-600
K833321 · Adel Medical , Ltd. · Nov 1983
DELIVERY 4 TABLE
K831309 · Amsco Co. · Jun 1983
S & W MODEL ASO
K830873 · S & W Enterprises, Inc. · May 1983
O.N.A.T.
K820175 · Latex Medical Devices, Inc. · Jan 1982
K831998 · BIRTHWELL BIRTHING SYSTEM
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