Cleared Traditional

K801868 - CAL-COUNT

K801868 is an FDA 510(k) clearance for CAL-COUNT, manufactured by Bayshore Systems Corp.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K801868 · Bayshore Systems Corp. · Physical Medicine device
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Aug 1980
Decision
22d
Days
Class 2
Risk

K801868 is an FDA 510(k) clearance for the CAL-COUNT. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Bayshore Systems Corp. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - the FDA physical medicine 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 - K801868

510(k) Number K801868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1980
Decision Date August 27, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 116d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ISD Exerciser, Measuring

All 59
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K801868.
3-D PASSIVE MOBILIZER
K834360 · 3-D Orthopedic, Inc. · Jan 1984
STATIONARY EXERCISE BICYCLE
K834098 · Engineering Dynamics Corp. · Dec 1983
ROTAGYM
K832940 · I-Rep, Inc. · Nov 1983
COMPUTRIM 900
K800939 · Amf, Inc. · May 1980
NUCLEAR STRESS TABLE (NST-1)
K800892 · Technicare Corp. · May 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · Victoreen, Inc. · Jan 1980
K801868 · CAL-COUNT
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