510(k) Report

510(k) · Cleared

Cleared

Capset Calcium Sulfate Bone Graft Plaster

K943186510(k) TraditionalCleared Apr 10, 1995279-day reviewClass II21 CFR 872.3930

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

Lifecore Biomedical, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Apr 10, 1995 after a 279-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Apr 10, 1995
Review
279 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943186 Capset Calcium Sulfate Bone Graft PlasterLifecore Biomedical, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK042730 Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0GLifecorebiomedical · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K042730Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0GLifecorebiomedical · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943186Capset Calcium Sulfate Bone Graft PlasterLifecore Biomedical, Inc.1995—
+1K042730Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0GLifecorebiomedical2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K943186, 1995–2005Source: 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 LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K042730Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0GLifecorebiomedical20050

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, K042730 (Lifecorebiomedical, 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

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

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

More from Lifecore Biomedical, Inc.

37 FDA decisions under this applicant name. See the company

  • K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007
  • K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
  • K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc. · 20072 recalls
  • K072572Primaconnex RD and WD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007
  • K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K943186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943186: Capset Calcium Sulfate Bone Graft Plaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943186

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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