510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022387Substantially Equivalent

Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic

Craftmatic Organization, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022387 is the FDA 510(k) clearance record for CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC, a class II device, cleared for Craftmatic Organization, Inc. on under FDA product code LLI (Bed, Therapeutic, Ac-Powered, Adjustable Home-Use). FDA records list one 510(k) clearance for Craftmatic Organization, Inc. As of , FDA records show no recalls naming K022387.

Clearance record

Decision date
Received
(58 days to decision)
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Applicant
Craftmatic Organization, Inc. 2550 M St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLI

Trailing 12 months

FDA records hold no clearances under product code LLI in the trailing twelve months.

FDA records show no clearances under product code LLI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260