Cleared Traditional

K991112 - SAGE CONTRAST MANAGEMENT SYSTEM

K991112 is an FDA 510(k) clearance for SAGE CONTRAST MANAGEMENT SYSTEM, manufactured by Sage Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K991112 · Sage Laboratories, Inc. · General Hospital
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Sep 1999
Decision
154d
Days
Class 2
Risk

K991112 is an FDA 510(k) clearance for the SAGE CONTRAST MANAGEMENT SYSTEM. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Sage Laboratories, Inc. (Shreveport, US). The FDA issued a Cleared decision on September 2, 1999 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sage Laboratories, Inc. devices

FDA 510(k) Submission Details - K991112

510(k) Number K991112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date September 02, 1999
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
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 761
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K991112.
BOLUS ACCESSORY SET
K992072 · I-Flow Corp. · Sep 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · The Kipp Group · Sep 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979 · Medtronic Minimed · Sep 1999
MED-RX EXTENSION SETS
K990777 · Benlan, Inc. · Aug 1999
PARSET, MODEL A10001E
K992104 · Rd Medical Mfg., Inc. · Aug 1999
INTRAVASCULAR ADMINISTRATION SET
K991932 · The Kipp Group · Aug 1999