Cleared Traditional

K060672 - ONE STICK Y EXTENSION SET AND VOLUMETER

K060672 is an FDA 510(k) clearance for ONE STICK Y EXTENSION SET AND VOLUMETER, manufactured by One Stick, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K060672 · One Stick, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
17d
Days
Class 2
Risk

K060672 is an FDA 510(k) clearance for the ONE STICK Y EXTENSION SET AND VOLUMETER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by One Stick, LLC (Lubbock, US). The FDA issued a Cleared decision on March 31, 2006 after a review of 17 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060672

510(k) Number K060672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date March 31, 2006
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 1143
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K060672.
K-SHIELD PORT ACCESS INFUSION SET
K060580 · Kawasumi Laboratories, Inc. · Jun 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · Health Line International Corporation · May 2006
TIANJIN MEDIS DISPOSABLE INFUSION SET
K060082 · Tianjin Medis International Trade Co., Ltd. · Mar 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · Baxter Healthcare Corp · Mar 2006
ALARIS SAFETY MALE LUER
K053049 · Cardinal Health, Alaris Products · Jan 2006
TEGO, MODEL D1000
K053106 · Icu Medical, Inc. · Jan 2006

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060672 · ONE STICK Y EXTENSION SET AND VOLUMETER
Download PDF FDA Summary One Stick, LLC