510(k) · Cleared

Cleared

Pressureguard: Selectcare

K960188510(k) TraditionalCleared Oct 2, 1996260-day reviewClass II21 CFR 880.5550

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

Span-America Medical Systems, Inc. · FNM Mattress, Air Flotation, Alternating Pressure

Cleared on Oct 2, 1996 as substantially equivalent to K951112 (Span-America Medical Systems, Inc., 1995) after a 260-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 2, 1996
Review: 260 days
Class: Class II
Product code: FNM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951112 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951112 Pressureguard IVSpan-America Medical Systems, Inc. · 1995
This deviceK960188 Pressureguard: SelectcareSpan-America Medical Systems, Inc. · 1996

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)	K960188	Pressureguard: Selectcare	Span-America Medical Systems, Inc.	1996	—

FIG. 1 — Lineage of K960188, 1995–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K951112	Pressureguard IV Summary page 1 …dent & CEQ Wanda J. Totton, Director of Quality January 8, 1995 PressureGuard: SelectCare Mattress System Powered Air Flotation Matiress Unknown PressureGuard [V, S10K951112 The PressureGusrd SelectCare is 2 powered air flotation matiress whick provides pressure-reducing support within a2 range of adj…	Span-America Medical Systems, Inc.	1995	—

Also cleared against K951112: 1 other device →

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.
1 other device also cites its predicate K951112.

How does its category compare?

All FNM devices

FNM 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

2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FNM

128in 2025

2007high 303 (2012) · low 33 (2007)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	33
2008	—	4	35
2009	—	0	33
2010	—	1	56
2011	—	0	291
2012	—	0	303
2013	—	0	223
2014	—	0	80
2015	—	0	80
2016	—	0	50
2017	—	0	56
2018	—	0	115
2019	—	0	101
2020	—	0	58
2021	—	0	47
2022	—	0	75
2023	—	0	197
2024	—	0	254
2025	—	1	128
2026	—	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/K960188 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960188: Pressureguard: Selectcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960188

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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