Cleared Traditional

K940405 - TELETOM

K940405 is an FDA 510(k) clearance for TELETOM, manufactured by Berchtold Holding GmbH. The device is a Class 1 General Hospital device with product code KMI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K940405 · Berchtold Holding GmbH · General Hospital
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Apr 1994
Decision
77d
Days
Class 1
Risk

K940405 is an FDA 510(k) clearance for the TELETOM. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Berchtold Holding GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on April 14, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - 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 - K940405

510(k) Number K940405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date April 14, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

KMI Device Classification - Class 1, General Controls

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMI Monitor, Bed Patient

All 16
Devices cleared under the same product code (KMI) and FDA review panel - the closest regulatory comparables to K940405.
INFORMER PLUS
K943481 · Micro-Tech Medical, Inc. · Nov 1994
PM-PAGER
K933552 · Hill Engineering · Sep 1994
HOME AMB-ALERT
K934344 · Medway · Apr 1994
SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1
K924433 · Senior Technologies, Inc. · Jun 1993
WANDER CARE
K925529 · Care Electronics, Inc. · Jun 1993
AMB-ALERT
K911079 · Medway · Sep 1991
K940405 · TELETOM
Download PDF Berchtold Holding GmbH