Cleared Traditional

K782001 - ROSEALAE

K782001 is an FDA 510(k) clearance for ROSEALAE, manufactured by Asmb. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K782001 · Asmb · General Hospital
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Dec 1978
Decision
3d
Days
Class 1
Risk

K782001 is an FDA 510(k) clearance for the ROSEALAE. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Asmb (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 3 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 Asmb devices

FDA 510(k) Submission Details - K782001

510(k) Number K782001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1978
Decision Date December 07, 1978
Days to Decision 3 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
126d faster than avg
Panel avg: 129d · This submission: 3d
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 K782001.
STERILIZATION PROCESS/BABY BLANKET
K792626 · Procter & Gamble Mfg. Co. · Jan 1980
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978
TOWELS, SHEETS, PILLOWCASES
K781227 · Abco Dealers, Inc. · Oct 1978
PILLOWS- SINGLE PATIENT USE
K781354 · Abco Dealers, Inc. · Oct 1978
SHEET KIT, STRETCHER, DISPOSABLE
K770486 · American Hospital Supply Corp. · Apr 1977