Cleared Traditional

K905250 - LOBOW

K905250 is an FDA 510(k) clearance for LOBOW, manufactured by Perinatal Systems. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K905250 · Perinatal Systems · Cardiovascular device
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Jan 1991
Decision
48d
Days
Class 2
Risk

K905250 is an FDA 510(k) clearance for the LOBOW. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Perinatal Systems (Mountain View, US). The FDA issued a Cleared decision on January 8, 1991 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: 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 Perinatal Systems devices

FDA 510(k) Submission Details - K905250

510(k) Number K905250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date January 08, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 367
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K905250.
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · Cook, Inc. · Feb 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · Scimed Life Systems, Inc. · Feb 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · Mallinckrodt Medical · Jan 1991
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH
K903417 · Vas-Cath, Inc. · Dec 1990
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER
K902367 · Vas-Cath, Inc. · Dec 1990