Cleared Abbreviated

HELIX HYDRO-JET (K012464) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K012464 · Andreas Pein Medizintechnik GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
70d
Days
Class 2
Risk

K012464 is an FDA 510(k) clearance for the HELIX HYDRO-JET. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Andreas Pein Medizintechnik GmbH (Golden, US). The FDA issued a Cleared decision on October 10, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andreas Pein Medizintechnik GmbH devices

Submission Details

510(k) Number K012464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2001
Decision Date October 10, 2001
Days to Decision 70 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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 - FQH Lavage, Jet

All 18
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ARTISAN PULSE LAVAGE SYSTEM
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K830386 · C.R. Bard, Inc. · Mar 1983
EXETER BONE LAUAGE SYSTEM
K790811 · Howmedica Corp. · Jul 1979