Cleared Traditional

K845038 - BREAST & FOREIGN BODY LOCALIZATION INST...

K845038 is the FDA 510(k) clearance for BREAST & FOREIGN BODY LOCALIZATION INST... by Ranfac, Corp.. It is a Class 1 General & Plastic Surgery device (product code GDF) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K845038 · Ranfac, Corp. · General & Plastic Surgery device
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Mar 1985
Decision
74d
Days
Class 1
Risk

K845038 is an FDA 510(k) clearance for the BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 74 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 Ranfac, Corp. devices

Submission Details

510(k) Number K845038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date March 11, 1985
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDF Guide, Needle, Surgical
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 - GDF Guide, Needle, Surgical

All 7
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K845038.
WILLIAMS ACS MARKER NEEDLE
K882036 · Buckman Co., Inc. · Jul 1988
BIOPSY ADAPTER #H4221BG
K864551 · General Electric Co. · Dec 1986
BIOPSY ADAPTER H4222W
K861050 · General Electric Co. · Apr 1986
MAYO-HEGAR NEEDLE HOLDER
K821289 · Conphar, Inc. · Jun 1982
OLSEN HEGAR NEEDLE HOLDERS
K821295 · Conphar, Inc. · Jun 1982
CONPHAR MAYO HEGAR NEEDLE HOLDER
K821354 · Conphar, Inc. · Jun 1982