510(k) · Cleared

Cleared

Cordcap

K091380510(k) TraditionalCleared Jul 30, 200980-day reviewClass U

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

Cleared on Jul 30, 2009 as substantially equivalent to K010070 (Ultradent Products, Inc., 2001) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jul 30, 2009
Review: 80 days
Class: Class U
Product code: MVL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K010070 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010070 Ultrapak NehaUltradent Products, Inc. · 2001
This deviceK091380 CordcapCentrix, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010070	Ultrapak Neha	Ultradent Products, Inc.	2001	—
0 (this device)	K091380	Cordcap	Centrix, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K091380, 2001–2009Source: 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 MVL? 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 MVL device

#1 K254239 CyClean Cordscore 11.4 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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
*	K010070	Ultrapak Neha Summary page 1 …ion Trade/Proprietary/Model Name: CordCapTM Classification Product Code: MVL 3) Devices to Which New Device is Substantially Equivalent: Ultrapak NEHA (K01 0070) Stay-Put Impregnated (K04 1023) 4) Device Description: CordCapTM is a compression roll manufactured out of wicking…	Ultradent Products, Inc.	2001	—
*	K041023	Stay-Put Impregnated Summary page 1 …: CordCapTM Classification Product Code: MVL 3) Devices to Which New Device is Substantially Equivalent: Ultrapak NEHA (K01 0070) Stay-Put Impregnated (K04 1023) 4) Device Description: CordCapTM is a compression roll manufactured out of wicking paper and impregnated with natur…	Coltene/Whaledent GmbH & Co. KG	2004	—

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?

None of the 2 ancestors has a recall.

How does its category compare?

All MVL devices

MVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MVL

1in 2025

2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVL

227in 2017

2007high 227 (2017) · low 79 (2010)2026

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

Recalls per year · MVL

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · MVL

1in 2025

2007high 7 (2012) · low 0 (2007)2025

MAUDE reports naming product code MVL, 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	0	—	0	0
2008	1	—	0	0
2009	3	91	0	1
2010	4	79	0	1
2011	2	—	0	0
2012	1	—	0	7
2013	2	—	0	5
2014	2	—	0	2
2015	2	—	0	0
2016	0	—	0	0
2017	4	227	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	2	—	0	0
2021	1	—	0	3
2022	2	—	0	1
2023	0	—	0	0
2024	0	—	0	1
2025	1	—	0	1
2026	2	—	1	—

What is it indicated for?

CordCapTM is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091380 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091380: Cordcap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091380

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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