510(k) · Cleared
ClearedPressureguard IV
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 Jun 6, 1995 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 6, 1995
- Review
- 88 days
- Class
- Class II
- Product code
- FNM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK951112 Pressureguard IVSpan-America Medical Systems, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK960620 Pressureguard: Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK960188 Pressureguard: SelectcareSpan-America Medical Systems, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK961159 Powered Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K960620Pressureguard: Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996 · cites it directly1descendant
- K960188Pressureguard: SelectcareSpan-America Medical Systems, Inc. · 1996 · cites it directly0descendants
- K961159Powered Low Air Loss Mattress SystemSpan-America Medical Systems, Inc. · 1996 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951112 | Pressureguard IV | Span-America Medical Systems, Inc. | 1995 | — |
| +1 | K960620 | Pressureguard: Low Air Loss Mattress System | Span-America Medical Systems, Inc. | 1996 | — |
| +1 | K960188 | Pressureguard: Selectcare | Span-America Medical Systems, Inc. | 1996 | — |
| +2 | 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 | 3 | 0 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K960620 (Span-America Medical Systems, Inc., 1996) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K951112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951112: Pressureguard IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951112
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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