510(k) · Cleared
ClearedSimpulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · FNM Mattress, Air Flotation, Alternating Pressure
Cleared on Nov 18, 1997 as substantially equivalent to K930673 (Kinetic Concepts, Inc., 1993) after a 133-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 18, 1997
- Review
- 133 days
- Class
- Class II
- Product code
- FNM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930673 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930673 PremiumKinetic Concepts, Inc. · 1993
- This deviceK972549 SimpulseKinetic Concepts, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930673 | Premium | Kinetic Concepts, Inc. | 1993 | — |
| 0 (this device) | K972549 | Simpulse | Kinetic Concepts, Inc. | 1997 | — |
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 FNM? 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 |
|---|---|---|---|
| * | K930673 | PremiumSummary page 1…pulse IL. Classification Name: Class II, Mattress, Air Flotation, Alternating Pressure; (per 21 CFR Section 880.5550) III. Substantial Equivalence: Premium 510(k) No. K930673 IV. Device Description: The SimpulseTM is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Repl… | 1993 |
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 FNM devicesFNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNM
FDA has decided no FNM device since 2007.
Median 510(k) review, days · FNM
Too few FNM 510(k)s in any year since 2007 to give a median.
Recalls per year · FNM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FNM
128in 2025
MAUDE reports naming product code FNM, 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 | 33 |
| 2008 | 0 | — | 4 | 35 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 1 | 56 |
| 2011 | 0 | — | 0 | 291 |
| 2012 | 0 | — | 0 | 303 |
| 2013 | 0 | — | 0 | 223 |
| 2014 | 0 | — | 0 | 80 |
| 2015 | 0 | — | 0 | 80 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 0 | — | 0 | 115 |
| 2019 | 0 | — | 0 | 101 |
| 2020 | 0 | — | 0 | 58 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 197 |
| 2024 | 0 | — | 0 | 254 |
| 2025 | 0 | — | 1 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Simpulse mattress is indicated for patients who would benefit from a pressure
relieving surface with the additional benefit of pulsation to assist in the prevention and
treatment of the complications of immobility such as skin breakdown and decubitus ulcers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972549: Simpulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972549
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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