Cleared Traditional

K973133 - BIG BAG 3000 PRESSURE INFUSOR

K973133 is an FDA 510(k) clearance for BIG BAG 3000 PRESSURE INFUSOR, manufactured by Byron Medical. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K973133 · Byron Medical · General Hospital
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Sep 1997
Decision
22d
Days
Class 2
Risk

K973133 is an FDA 510(k) clearance for the BIG BAG 3000 PRESSURE INFUSOR. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Byron Medical devices

FDA 510(k) Submission Details - K973133

510(k) Number K973133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 21, 1997
Decision Date September 12, 1997
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 454
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K973133.
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PULSE*SPRAY INJECTOR
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K961862 · Bio-Tek Instruments, Inc. · Feb 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996