Cleared Traditional

K881697 - BREAST LESION LOCALIZATION NEEDLE

K881697 is an FDA 510(k) clearance for BREAST LESION LOCALIZATION NEEDLE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K881697

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.

IZH Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K881697.
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
K885135 · Bennett X-Ray Corp. · Mar 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
MAMEX DC MG11
K881505 · Orion Corp. · Jun 1988
MAMEX DC MAG MG12
K881506 · Orion Corp. · Jun 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988