510(k) Report

510(k) · Cleared

Cleared

Craftmatic Electric Adjustable Bed

K840787510(k) TraditionalCleared Jun 13, 1984145-day reviewClass II21 CFR 880.5100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Contour, Inc. · LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

Cleared on Jun 13, 1984 after a 145-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 13, 1984
Review
145 days
Class
Class II
Product code
LLI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared19801990200020102020
  1. This deviceK840787 Craftmatic Electric Adjustable BedContour, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK022387 Craftmatic Adjustable Beds with Optional Heat & Massage, Models…Craftmatic Organization, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022387Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I…Craftmatic Organization, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K840787Craftmatic Electric Adjustable BedContour, Inc.1984—
+1K022387Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic…Craftmatic Organization, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K840787, 1984–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022387Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I…Craftmatic Organization, Inc.20020

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022387 (Craftmatic Organization, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LLI devices

LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLI

FDA has decided no LLI device since 2007.

Median 510(k) review, days · LLI

Too few LLI 510(k)s in any year since 2007 to give a median.

Recalls per year · LLI

6in 2025

2011: 12012: 12022: 12025: 6, 6 Class I2026 (partial year): 1, 1 Class I
2007high 6 (2025) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · LLI

26in 2025

2008: 12011: 22012: 12013: 32014: 82015: 132016: 42017: 442018: 172019: 952020: 162021: 32022: 112023: 202024: 202025: 26
2007high 95 (2019) · low 0 (2007)2025

MAUDE reports naming product code LLI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20100—00
20110—12
20120—11
20130—03
20140—08
20150—013
20160—04
20170—044
20180—017
20190—095
20200—016
20210—03
20220—111
20230—020
20240—020
20250—6 (6)26
20260—1 (1)—

Recent decisions in LLI

The LLI category page

  • K022387Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, Iii & ClassicCraftmatic Organization, Inc. · 2002

https://510kreport.com/device/K840787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840787: Craftmatic Electric Adjustable Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840787

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026