PMA · Approved

Recalled · Class II · 2012

Superstat

P810040PMAApproved Jan 29, 1982177-day reviewClass III21 CFR 878.4490Recalls 13

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

Superstat Corp. · LMF Agent, Absorbable Hemostatic, Collagen Based

Approved on Jan 29, 1982 through premarket approval, which rests on the device’s own clinical evidence after a 177-day review. It has been recalled 13 times.

Decided: Jan 29, 1982
Review: 177 days
Class: Class III
Product code: LMF
Recalls: 13

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P810040 has 5 supplements since 1982: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1982high 2 (1984) · low 0 (1983)1995

View FIG. 1 as a table

Year	Supplements approved
1982	1
1984	2
1989	1
1995	1

FIG. 1 — Supplements to P810040, 1982–1995Source: FDA PMA database

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMF? 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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Does it have a predicate?

PMA decisions do not claim a predicate 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 24, 2012	Class II	Z-0331-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0335-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0337-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0338-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0343-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0332-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0340-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0341-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0333-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0334-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0336-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0339-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
Oct 24, 2012	Class II	Z-0342-2013	Process control	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LMF devices

LMF Agent, Absorbable Hemostatic, Collagen Based: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMF

16in 2025

2007high 37 (2014) · low 11 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMF

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

Recalls per year · LMF

2in 2023

2007high 16 (2012) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LMF

93in 2025

2007high 271 (2023) · low 15 (2007)2025

MAUDE reports naming product code LMF, 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	22	—	0	15
2008	11	—	1	55
2009	11	—	0	63
2010	14	—	0	76
2011	11	—	0	85
2012	14	—	16 (2)	51
2013	33	—	0	62
2014	37	—	0	93
2015	22	—	0	94
2016	15	—	0	85
2017	12	—	0	121
2018	16	—	0	109
2019	23	—	0	151
2020	15	—	0	146
2021	27	—	0	96
2022	16	—	0	58
2023	20	—	2	271
2024	18	—	0	134
2025	16	—	0	93
2026	15	—	1	—

https://510kreport.com/device/P810040 · printed Nov 4, 2026

Cite this page

510(k) Report. “P810040: Superstat.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P810040

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026