Cleared Traditional

K823899 - INFANT CARE SYSTEM

K823899 is an FDA 510(k) clearance for INFANT CARE SYSTEM, manufactured by Narco Scientific. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K823899 · Narco Scientific · General Hospital
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Apr 1983
Decision
108d
Days
Class 2
Risk

K823899 is an FDA 510(k) clearance for the INFANT CARE SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on April 14, 1983 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Narco Scientific devices

FDA 510(k) Submission Details - K823899

510(k) Number K823899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date April 14, 1983
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 339
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K823899.
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K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983
NON-STERILE REUSABLE NEEDLES
K823255 · Vertex Medical Corp. · Nov 1982
HYPOSERMIC NEEDLES
K813545 · Optical Micro Systems, Inc. · Jan 1982
MEDISYSTEMS NEEDLES & SYRINGES
K812910 · Medisystems Corp. · Nov 1981