Cleared Traditional

K023595 - BURETTE-IN LINE (150 ML)

K023595 is an FDA 510(k) clearance for BURETTE-IN LINE (150 ML), manufactured by Tuta Healthcare Pty Limited. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K023595 · Tuta Healthcare Pty Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
51d
Days
Class 2
Risk

K023595 is an FDA 510(k) clearance for the BURETTE-IN LINE (150 ML). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Tuta Healthcare Pty Limited (Sydney Nsw, AU). The FDA issued a Cleared decision on December 18, 2002 after a review of 51 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.

View all Tuta Healthcare Pty Limited devices

FDA 510(k) Submission Details - K023595

510(k) Number K023595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date December 18, 2002
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 890
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K023595.
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9
K030137 · Avail Medical Products, Inc. · Feb 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · Abbott Laboratories · Jan 2003
PREPARE ADMINISTRATION SET
K023769 · Appro Healthcare, Inc. · Dec 2002
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
K023469 · Victus, Inc. · Dec 2002
EXEL VACULET BLOOD COLLECTION SET
K020533 · Exelint Intl. Co. · Dec 2002
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
K023585 · Intravascular Incorporated · Nov 2002