Cleared Traditional

K080042 - SPIRUS MEDICAL SURGICAL INSTRUMENT

K080042 is an FDA 510(k) clearance for SPIRUS MEDICAL SURGICAL INSTRUMENT, manufactured by Spirus Medical, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K080042 · Spirus Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
86d
Days
Class 1
Risk

K080042 is an FDA 510(k) clearance for the SPIRUS MEDICAL SURGICAL INSTRUMENT. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Spirus Medical, Inc. (Ayer, US). The FDA issued a Cleared decision on April 3, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - 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: 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 Spirus Medical, Inc. devices

FDA 510(k) Submission Details - K080042

510(k) Number K080042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2008
Decision Date April 03, 2008
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

KMJ Device Classification - Class 1, General Controls

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
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.

Regulatory Peers - KMJ Lubricant, Patient

All 31
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K080042.
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