Cleared Traditional

MODEL 2100 FETAL MONITOR (K837102) - FDA 510(k) Clearance

K837102 · Huntleigh Group , Ltd. · Radiology device
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Mar 1983
Decision
66d
Days
-
Risk

K837102 is an FDA 510(k) clearance for the MODEL 2100 FETAL MONITOR.

Submitted by Huntleigh Group , Ltd. (Luton Beds Lu1 1uu, GB). The FDA issued a Cleared decision on March 14, 1983 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. 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 Huntleigh Group , Ltd. devices

Submission Details

510(k) Number K837102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date March 14, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -