Cleared Traditional

K873522 - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM

K873522 is an FDA 510(k) clearance for BARD AMBULATORY PCA DRUG DELIVERY SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K873522 · C.R. Bard, Inc. · General Hospital
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Dec 1987
Decision
119d
Days
Class 2
Risk

K873522 is an FDA 510(k) clearance for the BARD AMBULATORY PCA DRUG DELIVERY SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 119 days - within the typical 510(k) review window.

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. 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K873522

510(k) Number K873522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date December 29, 1987
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K873522.
BETATRON IV SYSTEM
K872774 · Cardiac Pacemakers, Inc. · Jan 1988
RESERVOIR BAG
K873494 · Marquette Medical, Inc. · Dec 1987
PUMP TUBING SET
K873495 · Marquette Medical, Inc. · Dec 1987
INFUMED 300 AMBULATORY INFUSION PUMP
K873961 · Med Fusion Systems, Inc. · Dec 1987
BARD MICROINFUSER I INSULIN INFUSION PUMP
K871807 · C.R. Bard, Inc. · Dec 1987
IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · Y · Dec 1987