510(k) · Cleared

Cleared

SPR Plus II Overlay System (CL250/CL212

K961854510(k) TraditionalCleared Aug 9, 199687-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

Gaymar Industries, Inc. · FNM Mattress, Air Flotation, Alternating Pressure

Cleared on Aug 9, 1996 after an 87-day review. The FDA summary names its predicate without a number.

Decided: Aug 9, 1996
Review: 87 days
Class: Class II
Product code: FNM
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K961854Source: FDA 510(k) database · 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
*	—	CLA 1500 System Named without a submission number			—

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.

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?

The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing 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/K961854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961854: SPR Plus II Overlay System (CL250/CL212.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961854

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026