510(k) · Cleared

Cleared

Pressureguard IV

K972486510(k) TraditionalCleared Feb 20, 1998233-day reviewClass II21 CFR 890.5225

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. · IKZ Bed, Patient Rotation, Powered

Cleared on Feb 20, 1998 as substantially equivalent to K953503 (Span-America Medical Systems, Inc., 1995) after a 233-day review. Its family tree reaches back 1 generation to 1995.

Decided: Feb 20, 1998
Review: 233 days
Class: Class II
Product code: IKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953503 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK953503 Pressureguard IVSpan-America Medical Systems, Inc. · 1995
This deviceK972486 Pressureguard IVSpan-America Medical Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953503	Pressureguard IV	Span-America Medical Systems, Inc.	1995	—
0 (this device)	K972486	Pressureguard IV	Span-America Medical Systems, Inc.	1998	—

FIG. 1 — Lineage of K972486, 1995–1998Source: 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 IKZ? 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
*	K953503	Pressureguard IV Summary page 1 …g Pressure Mattress Classification Name: Alternating Pressure Air Flotation Mattress, CFR 880.5550, Classification No. 80 FMN. 3. Predicate Device: PressureGuard IV, 510K953503 4. Description: The PressureGuard IV is an air flotation, alternating pressure support system. It consists of a foam shell manuf…	Span-America Medical Systems, Inc.	1995	—

Also cleared against K953503: 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 K953503.

How does its category compare?

All IKZ devices

IKZ Bed, Patient Rotation, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKZ

FDA has decided no IKZ device since 2007.

Median 510(k) review, days · IKZ

Too few IKZ 510(k)s in any year since 2007 to give a median.

Recalls per year · IKZ

1in 2021

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · IKZ

12in 2025

2007high 294 (2013) · low 4 (2008)2025

MAUDE reports naming product code IKZ, 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	7
2008	—	0	4
2009	—	0	11
2010	—	1	26
2011	—	1	48
2012	—	0	69
2013	—	1	294
2014	—	0	80
2015	—	0	40
2016	—	0	26
2017	—	0	35
2018	—	1	28
2019	—	0	27
2020	—	0	29
2021	—	1	11
2022	—	0	6
2023	—	0	20
2024	—	0	7
2025	—	0	12
2026	—	0	—

What is it indicated for?

For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.

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/K972486 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972486: Pressureguard IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972486

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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