Cleared Traditional

K840273 - LOPEZ LOCK

K840273 is an FDA 510(k) clearance for LOPEZ LOCK, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K840273 · Icu Medical, Inc. · General Hospital
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Mar 1984
Decision
43d
Days
Class 2
Risk

K840273 is an FDA 510(k) clearance for the LOPEZ LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Walker, US). The FDA issued a Cleared decision on March 6, 1984 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K840273

510(k) Number K840273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date March 06, 1984
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K840273.
SOLUTION ADMIN. SET STERILE
K840410 · Loversan · Mar 1984
MESULIN INSULIN INFUSION SET
K833398 · Molnlycke A/S Hospital Products · Mar 1984
CONCENTRATED PLATELET ADMIN. SET
K840212 · American Mcgaw · Mar 1984
PBC EXTENSION SET
K834252 · Philadelphia Biologics Center · Feb 1984
PBC IV SET NON-VENTED
K834253 · Philadelphia Biologics Center · Feb 1984
PBC IV SET VENTED
K834254 · Philadelphia Biologics Center · Feb 1984
K840273 · LOPEZ LOCK
Download PDF Icu Medical, Inc.