Cleared Traditional

K942271 - LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE

K942271 is an FDA 510(k) clearance for LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE, manufactured by Level 1 Technologies, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K942271 · Level 1 Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
428d
Days
Class 2
Risk

K942271 is an FDA 510(k) clearance for the LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Level 1 Technologies, Inc. (Rockland, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

View all Level 1 Technologies, Inc. devices

FDA 510(k) Submission Details - K942271

510(k) Number K942271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1994
Decision Date July 12, 1995
Days to Decision 428 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 129d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 771
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K942271.
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · Baxter Healthcare Corp · Jul 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · Imed Corp. · Jul 1995
FILTERED EXTENSION SETS
K942988 · B. Braun of America, Inc. · Jul 1995
SMARTFLOW I ADMINISTRATION SET
K945298 · River Medical, Inc. · Jun 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
K952053 · Becton Dickinson Vascular Access, Inc. · May 1995
LOW VOLUME MULTIPORT
K943770 · B. Braun of America, Inc. · Apr 1995