Cleared Traditional

K831309 - DELIVERY 4 TABLE

K831309 is an FDA 510(k) clearance for DELIVERY 4 TABLE, manufactured by Amsco Co.. The device is a Class 2 Obstetrics & Gynecology device with product code KNC cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K831309 · Amsco Co. · Obstetrics & Gynecology device
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Jun 1983
Decision
54d
Days
Class 2
Risk

K831309 is an FDA 510(k) clearance for the DELIVERY 4 TABLE. Classified as Table, Obstetric (and Accessories) (product code KNC), Class II - Special Controls.

Submitted by Amsco Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 54 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 - K831309

510(k) Number K831309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date June 15, 1983
Days to Decision 54 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
107d faster than avg
Panel avg: 161d · This submission: 54d
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 25
Devices cleared under the same product code (KNC) and FDA review panel - the closest regulatory comparables to K831309.
LORRAINE DSL LABOR & DELIVERY BED
K842962 · Pulley-Kellam Co., Inc. · Sep 1984
LABOR/DELIVERY/RECOVERY BED LDR-600
K833321 · Adel Medical , Ltd. · Nov 1983
BIRTHWELL BIRTHING SYSTEM
K831998 · Qulab Co. · Sep 1983
S & W MODEL ASO
K830873 · S & W Enterprises, Inc. · May 1983
O.N.A.T.
K820175 · Latex Medical Devices, Inc. · Jan 1982
CENTURY BIRTHING CHAIR
K811902 · Century Manufacturing Co. · Aug 1981
K831309 · DELIVERY 4 TABLE
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