510(k) · Cleared
ClearedPressureguard: Low Air Loss Mattress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Span-America Medical Systems, Inc. · FNM Mattress, Air Flotation, Alternating Pressure
Cleared on Apr 25, 1996 as substantially equivalent to K951112 (Span-America Medical Systems, Inc., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 25, 1996
- Review
- 72 days
- Class
- Class II
- Product code
- FNM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951112 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951112 Pressureguard IVSpan-America Medical Systems, Inc. · 1995
- This deviceK960620 Pressureguard: Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK961159 Powered Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K961159Powered Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951112 | Pressureguard IV | Span-America Medical Systems, Inc. | 1995 | — |
| 0 (this device) | K960620 | Pressureguard: Low Air Loss Mattress System | Span-America Medical Systems, Inc. | 1996 | — |
| +1 | K961159 | Powered Low Air Loss Mattress System | Span-America Medical Systems, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 |
|---|---|---|---|
| * | K951112 | Pressureguard IVSummary page 1…Wanda J. Totton, Director of Quality February 8, 1996 PressureGuard: Low Air Loss Mattress System Powered Low Air Loss Mattress System Unknown PressureGuard® [V, 510K951112. The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to t… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961159 | Powered Low Air Loss Mattress System | 1996 | 0 |
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?
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?
For the prevention and treatment of pressure 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/K960620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960620: Pressureguard: Low Air Loss Mattress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960620
Report an extraction error
Are you the manufacturer?
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