Cleared Traditional

K052773 - B. BRAUN 0.2 MICRON FILTER

K052773 is an FDA 510(k) clearance for B. BRAUN 0.2 MICRON FILTER, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K052773 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
113d
Days
Class 2
Risk

K052773 is an FDA 510(k) clearance for the B. BRAUN 0.2 MICRON FILTER. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on January 24, 2006 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K052773

510(k) Number K052773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date January 24, 2006
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 483
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K052773.
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · Amsino International, Inc. · Jun 2006
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · Terumo Europe N.V. · Apr 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
PROCEDUR-10
K052075 · Avanca Medical Devices, Inc. · Nov 2005
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · Orthovita, Inc. · Oct 2005
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · Devon Safety Products, Inc. · Sep 2005