Cleared Traditional

K881697 - BREAST LESION LOCALIZATION NEEDLE

K881697 is the FDA 510(k) clearance for BREAST LESION LOCALIZATION NEEDLE by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Radiology device
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Sep 1988
Decision
148d
Days
Class 2
Risk

K881697 is an FDA 510(k) clearance for the BREAST LESION LOCALIZATION NEEDLE. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 14, 1988 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K881697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date September 14, 1988
Days to Decision 148 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 107d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K881697.
CYTOGUIDE
K885020 · Philips Medical Systems North America, Inc. · Apr 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · Elscint, Inc. · Jan 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · Elscint, Inc. · Jan 1989
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · Fischer Imaging Corp. · May 1988
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · Fischer Imaging Corp. · Dec 1986