Cleared Traditional

K812069 - BORES* DEPTH GAUGE

K812069 is the FDA 510(k) clearance for BORES* DEPTH GAUGE by Santa Barbara Medco, Inc.. It is a Class 1 General & Plastic Surgery device (product code FTY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K812069 · Santa Barbara Medco, Inc. · General & Plastic Surgery device
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Aug 1981
Decision
41d
Days
Class 1
Risk

K812069 is an FDA 510(k) clearance for the BORES* DEPTH GAUGE. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Santa Barbara Medco, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Santa Barbara Medco, Inc. devices

Submission Details

510(k) Number K812069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 31, 1981
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FTY Tape, Measuring, Rulers And Calipers

All 10
Devices cleared under the same product code (FTY) and FDA review panel - the closest regulatory comparables to K812069.
LN 100 BREAST MARKER
K872319 · Instrumentation Industries, Inc. · Aug 1987
ZIMMER OSSIMETER
K832899 · Zimmer, Inc. · Oct 1983
SAGITTAL KNEE TESTER
K831041 · Orthopedic Systems, Inc. · Jun 1983
EXTENDED TUMOR CALIPER
K811278 · Mick Radio-Nuclear Instruments, Inc. · Jun 1981
PROXIMATE (TMD) TISSUE MEASURING DEVICE
K801374 · Ethicon, Inc. · Jun 1980
SURGICAL RULER
K790660 · Richard-Allan Medical Ind., Inc. · Apr 1979