Cleared Traditional

K131851 - OSTEOMED NEURO RONGEUR

K131851 is an FDA 510(k) clearance for OSTEOMED NEURO RONGEUR, manufactured by Osteomed. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K131851 · Osteomed · Neurology device
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Dec 2013
Decision
168d
Days
Class 2
Risk

K131851 is an FDA 510(k) clearance for the OSTEOMED NEURO RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 168 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteomed devices

FDA 510(k) Submission Details - K131851

510(k) Number K131851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date December 06, 2013
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 149d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 Neurology devices follow this clearance model.

Regulatory Peers - HAE Rongeur, Manual

All 28
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K131851.
Kerrison Rongeurs
K152734 · Vitalitec Medizintechnik GmbH · Jun 2016
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K150468 · K2 Medical GmbH & Co. KG · Feb 2016
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K150428 · Integra Lifesciences Corp. · Apr 2015
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · Symmetry Surgical · Aug 2013
IO-TOME DEVICE
K113073 · Baxano, Inc. · Jul 2012
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K113533 · Baxano, Inc. · Apr 2012