Cleared Traditional

K771942 - TILT 10

K771942 is the FDA 510(k) clearance for TILT 10 by Affiliated Hospital Products, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HDD) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K771942 · Affiliated Hospital Products, Inc. · Obstetrics & Gynecology device
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Oct 1977
Decision
10d
Days
Class 2
Risk

K771942 is an FDA 510(k) clearance for the TILT 10, CATALOG #S-2600. Classified as Table, Obstetrical, Ac-powered (and Accessories) (product code HDD), Class II - Special Controls.

Submitted by Affiliated Hospital Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1977 after a review of 10 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.

View all Affiliated Hospital Products, Inc. devices

Submission Details

510(k) Number K771942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date October 27, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d faster than avg
Panel avg: 160d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDD Table, Obstetrical, Ac-powered (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.