Cleared Traditional

K853970 - ALPHA CHUCK

K853970 is an FDA 510(k) clearance for ALPHA CHUCK, manufactured by Rocky Mountain Medical Corp.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K853970 · Rocky Mountain Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
43d
Days
Class 1
Risk

K853970 is an FDA 510(k) clearance for the ALPHA CHUCK. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Rocky Mountain Medical Corp. (Greenwood Village, US). The FDA issued a Cleared decision on November 8, 1985 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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 Rocky Mountain Medical Corp. devices

FDA 510(k) Submission Details - K853970

510(k) Number K853970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1985
Decision Date November 08, 1985
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

All 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K853970.
KIMLON DISPOSABLE BLANKET
K863179 · Kimberly-Clark Corp. · Aug 1986
SINGLE-USE PATIENT UNDERPAD
K862348 · Procter & Gamble Mfg. Co. · Jul 1986
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
SHAVE PREP KITS
K842989 · Biological & Environmental Control Laboratories · Dec 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · Biological & Environmental Control Laboratories · Dec 1984