Cleared Traditional

K955829 - SAFPACE SYSTEM

K955829 is an FDA 510(k) clearance for SAFPACE SYSTEM, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 693-day FDA review.

K955829 · B.Braun Medical, Inc. · Cardiovascular device
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Nov 1997
Decision
693d
Days
Class 2
Risk

K955829 is an FDA 510(k) clearance for the SAFPACE SYSTEM. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 18, 1997 after a review of 693 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K955829

510(k) Number K955829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date November 18, 1997
Days to Decision 693 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
568d slower than avg
Panel avg: 125d · This submission: 693d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K955829.
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
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TEMPORARY CARDIAC PACING WIRE
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INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K971775 · Cardiac Control Systems, Inc. · Dec 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · Harmac Medical Products, Inc. · Oct 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · Harmac Medical Products, Inc. · Aug 1997
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997