510(k) · Cleared
ClearedCraftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, Iii & Classic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Craftmatic Organization, Inc. · LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Cleared on Sep 19, 2002 as substantially equivalent to K840787 (Contour, Inc., 1984) after a 58-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Sep 19, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- LLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840787 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK840787 Craftmatic Electric Adjustable BedContour, Inc. · 1984
- This deviceK022387 Craftmatic Adjustable Beds with Optional Heat & Massage, Models…Craftmatic Organization, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840787 | Craftmatic Electric Adjustable Bed | Contour, Inc. | 1984 | — |
| 0 (this device) | K022387 | Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic… | Craftmatic Organization, Inc. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K840787 | Craftmatic Electric Adjustable BedSummary page 1…ator (21 C.F.R. $ 880.5100). Legally Marketed Predicate Device: Craftmatic@ Adjustable Bed. The Craftmatic@ Adjustable Bed was initially cleared by FDA on June 13,1984 (K840787B). Device Description: Craftmatic@ Adjustable Beds are electrically powered adjustable beds for home use that adjust into 1001 v… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LLI devicesLLI 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
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · LLI
26in 2025
MAUDE reports naming product code LLI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 95 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 6 (6) | 26 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
May Provide Temporary Relief of Low Back Pain; May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatigue or Overexertion; May Provide Temporary Relief of Edema or Swelling of the Legs; May Provide Temporary Relief of Poor Local Blood Circulation of the Legs; May Provide Temporary Relief from Symptoms of Hiatus Hernia; May Provide Temporary Relief from the Symptoms of Gastric Reflux; May Provide Temporary Relief of Nighttime Heartburn…
Read the full statement (109 words)
May Provide Temporary Relief of Low Back Pain;
May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatigue or Overexertion;
May Provide Temporary Relief of Edema or Swelling of the Legs;
May Provide Temporary Relief of Poor Local Blood Circulation of the Legs;
May Provide Temporary Relief from Symptoms of Hiatus Hernia;
May Provide Temporary Relief from the Symptoms of Gastric Reflux;
May Provide Temporary Relief of Nighttime Heartburn;
The Optional Heating Accessory Provides Temporary Relief from Mild Arthritis and Joint Pain, as well as Muscle Pain Associated with Stress and Tension; and
Sleeping in an Upright Position May Reduce or Ease Light and Occasional Snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022387: Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, Iii & Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022387
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026