Cleared Traditional

K973593 - BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5

K973593 is an FDA 510(k) clearance for BRIDGE SENTRY BEDSIDE UNIT, manufactured by Bridge Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K973593 · Bridge Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
337d
Days
Class 2
Risk

K973593 is an FDA 510(k) clearance for the BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGU.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bridge Medical, Inc. (Solona Beach, US). The FDA issued a Cleared decision on August 25, 1998 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bridge Medical, Inc. devices

FDA 510(k) Submission Details - K973593

510(k) Number K973593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date August 25, 1998
Days to Decision 337 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 129d · This submission: 337d
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 527
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K973593.
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · Sims Deltec, Inc. · Nov 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · Alexander Mfg. Co. · Aug 1998
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
K980738 · Byron Medical · Jun 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998