510(k) Report

510(k) · Cleared

Cleared

Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS

K011487510(k) TraditionalCleared Nov 21, 2001190-day reviewClass II21 CFR 870.3470

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

Somanetics Corp. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Nov 21, 2001 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 21, 2001
Review
190 days
Class
Class II
Product code
DXZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared200020052010201520202025
  1. This deviceK011487 Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPSSomanetics Corp. · 2001
  2. Descendant · cites it directly · 0 of its ownK031586 Correstore Patch SystemSomanetics Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K031586Correstore Patch SystemSomanetics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011487Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPSSomanetics Corp.2001—
+1K031586Correstore Patch SystemSomanetics Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K011487, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXZ device

  1. #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031586Correstore Patch SystemSomanetics Corp.20030

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, K031586 (Somanetics Corp., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXZ

1in 2025

2007: 12008: 22009: 12010: 32011: 22012: 12013: 12014: 32015: 22016: 22017: 12020: 12025: 1
2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2010: 91 days median2014: 106 days median
2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2010: 22011: 22013: 22018: 12020: 12023: 22025: 2, 2 Class I2026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DXZ

119in 2025

2007: 502008: 62009: 1092010: 812011: 472012: 212013: 692014: 932015: 1712016: 662017: 302018: 442019: 552020: 1212021: 802022: 772023: 402024: 492025: 119
2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—050
20082—06
20091—0109
2010391281
20112—247
20121—021
20131—269
20143106093
20152—0171
20162—066
20171—030
20180—144
20190—055
20201—1121
20210—080
20220—077
20230—240
20240—049
20251—2 (2)119
20260—1—

More from Somanetics Corp.

12 FDA decisions under this applicant name. See the company

  • K093422Vital Sync Model 5000 SeriesSomanetics Corp. · 2010
  • K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics Corp. · 2009
  • K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  • K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  • K051274Invos SystemSomanetics Corp. · 2005

Recent decisions in DXZ

The DXZ category page

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025
  • K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. · 2020
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

https://510kreport.com/device/K011487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011487: Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011487

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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