Cleared Traditional

K812075 - NICHOLE'S 99

K812075 is an FDA 510(k) clearance for NICHOLE'S 99, manufactured by Healthcare Ind.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812075 · Healthcare Ind. · General Hospital
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Aug 1981
Decision
21d
Days
Class 2
Risk

K812075 is an FDA 510(k) clearance for the NICHOLE'S 99. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Healthcare Ind. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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.

View all Healthcare Ind. devices

FDA 510(k) Submission Details - K812075

510(k) Number K812075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 12, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 - CAH Filter, Bacterial, Breathing-circuit

All 86
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K812075.
BREATHING CIRCUIT BACTERIA FILTER
K831856 · Vital Signs, Inc. · Sep 1983
BREATHING FILTER
K830618 · Ohio Medical Products · Apr 1983
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · Ohio Medical Products · Dec 1982
RESPIRGARD
K802763 · Marquest Medical Products, Inc. · Nov 1980
VENTILATOR TUBE WITH FILTER
K791773 · Pharmaseal Div., Baxter Healthcare Corp. · Oct 1979
UNIPOR BREATHING CIRCUIT FILTER
K791307 · Pall Biomedical Products Co. · Aug 1979