Cleared Traditional

K972854 - PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY

K972854 is an FDA 510(k) clearance for PROTOS I.V. ADMINISTRATION SET (15 DROP..., manufactured by Globe Ent., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K972854 · Globe Ent., Inc. · General Hospital
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Dec 1997
Decision
138d
Days
Class 2
Risk

K972854 is an FDA 510(k) clearance for the PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELI.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Globe Ent., Inc. (Houston, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 138 days - within the typical 510(k) review window.

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 Globe Ent., Inc. devices

FDA 510(k) Submission Details - K972854

510(k) Number K972854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date December 17, 1997
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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 656
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K972854.
SMARTVALVE
K974589 · Icu Medical, Inc. · Jan 1998
V3 VALVE
K974145 · B.Braun Medical, Inc. · Jan 1998
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
K972839 · Globe Ent., Inc. · Dec 1997
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
K974013 · Sims Deltec, Inc. · Dec 1997
EXEL I.V. ADMINISTRATION SET
K963659 · Exel Intl. · Dec 1997
POSITIVE PRESSURE CONNECTOR
K973167 · Icu Medical, Inc. · Nov 1997