Cleared Traditional

K123006 - AIR BARRIER SYSTEM (ABS)

K123006 is an FDA 510(k) clearance for AIR BARRIER SYSTEM (ABS), manufactured by Nimbic Systems, Inc.. The device is a Class 2 General Hospital device with product code ORC cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K123006 · Nimbic Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
449d
Days
Class 2
Risk

K123006 is an FDA 510(k) clearance for the AIR BARRIER SYSTEM (ABS). Classified as Air Filter Portable Apparatus (product code ORC), Class II - Special Controls.

Submitted by Nimbic Systems, Inc. (Houston, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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: 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 General Hospital submissions.

FDA 510(k) Submission Details - K123006

510(k) Number K123006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date December 20, 2013
Days to Decision 449 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
320d slower than avg
Panel avg: 129d · This submission: 449d
Pathway characteristics
Predicate-based equivalence.

ORC Device Classification - Class 2, Special Controls

Product Code ORC Air Filter Portable Apparatus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
Definition The Sytem Is Intended To Control The Surgical Environment To Prevent Bacterial Contamination During Surgical Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General Hospital devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01559506 Completed Interventional Industry-sponsored

Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

ABS to Reduce Contamination in Spine Surgery

41
Patients (actual)
1
Site
Basic_science
Purpose
Double blind
Masking
Condition studied Surgery
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Rabih O Darouiche, MD
Sponsor Nimbic Systems, LLC (industry)
Started 2011-11-01 → Primary completion 2015-02-01
Primary outcome
CFU Density
View full study on ClinicalTrials.gov
K123006 · AIR BARRIER SYSTEM (ABS)
Download PDF FDA Summary Nimbic Systems, Inc.