Cleared Traditional

K823845 - PORT-LOCK

K823845 is an FDA 510(k) clearance for PORT-LOCK, manufactured by Norfolk Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K823845 · Norfolk Medical Products, Inc. · General Hospital
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Mar 1983
Decision
70d
Days
Class 2
Risk

K823845 is an FDA 510(k) clearance for the PORT-LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 70 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 - K823845

510(k) Number K823845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 01, 1983
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 1142
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K823845.
IDAS INFUSION SET
K830194 · Idas America, Ltd. · Mar 1983
INFUSION PUMP RETROGRADE EXTEN. AS 715
K830654 · Narco Scientific · Mar 1983
SECURA SET SECONDARY ADMIN. SET
K830565 · Diatek, Inc. · Mar 1983
SECURA SET PRIMARY ADMIN. SET
K830377 · Diatek, Inc. · Mar 1983
SECURA SET VOLUME LIMITING SET
K830448 · Diatek, Inc. · Feb 1983
CENTAURSET 300 & 300 P.E.D
K830258 · Centaur Sciences, Inc. · Feb 1983
K823845 · PORT-LOCK
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