Cleared Traditional

K950098 - NEEDLE SAFETY COVER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K950098 · Hammer-Plane, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
213d
Days
Class 1
Risk

K950098 is an FDA 510(k) clearance for the NEEDLE SAFETY COVER. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Hammer-Plane, Inc. (Simi Valley, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 213 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1100 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hammer-Plane, Inc. devices

Submission Details

510(k) Number K950098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date August 11, 1995
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 139d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBT Arterial Blood Sampling Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1100
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.