510(k) · Cleared

Cleared

Desara Mesh Sling, Model Cal-DS01

K072456510(k) SpecialCleared May 8, 2008251-day reviewClass II21 CFR 878.3300

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

Caldera Medical, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on May 8, 2008 as substantially equivalent to K050516 (Herniamesh S.R.L., 2006) after a 251-day review. Its family tree reaches back 3 generations to 1998. 10 later devices descend from it.

Decided: May 8, 2008
Review: 251 days
Class: Class II
Product code: OTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K974098 (1998). 6 ancestors in all. 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
2 generations backK020652 Herniamesh T-SlingHerniamesh · 2002
1 generation backK050516 T-SlingHerniamesh S.R.L. · 2006
This deviceK072456 Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008
Descendant · cites it directly · 5 of its ownK101169 Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010
Descendant · 2 generations on · 3 of its ownK112609 Desara MeshCaldera Medical, Inc. · 2011
Descendant · cites it directly · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
Descendant · 3 generations on · 1 of its ownK132069 Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013
Descendant · cites it directly · 1 of its ownK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 4 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all

K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010 · cites it directly5descendants
K112609Desara MeshCaldera Medical, Inc. · 2011 · 2 generations on3descendants
K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · cites it directly3descendants
K132069Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013 · 3 generations on1descendant
K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K974098	Pubouurethral Sling	ETHICON, Inc.	1998	—
−2	K020652	Herniamesh T-Sling	Herniamesh	2002	—
−1	K050516	T-Sling	Herniamesh S.R.L.	2006	—
0 (this device)	K072456	Desara Mesh Sling, Model Cal-DS01	Caldera Medical, Inc.	2008	—
+1	K101169	Desara Mesh Model: Cal-DS01	Caldera Medical, Inc.	2010	—
+2	K112609	Desara Mesh	Caldera Medical, Inc.	2011	—
+1	K083471	GMD Universal Sling, Model Product Code 1010 and 1020	Generic Medical Device, Inc.	2009	2
+3	K132069	Desara Mesh, Desara Blue	Caldera Medical, Inc.	2013	—
+1	K101440	GMD Universal Urinary Incontinence Sling, Model 1012	Generic Medical Devices, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	4	0
2013	2	0
2014	1	0

FIG. 1 — Lineage of K072456, 1998–2014Source: 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 OTN? 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 OTN device

#1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 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? (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
*	K050516	T-Sling Summary page 1 …ass: Class Il, Product Code OTN, 21 CFR 878.3300, Gynecologic, For Stress Urinary Incontinence, Female, Obstetrics/Gynecology Panel 3. Predicate Device Caldera T-Sling, K050516, Feb 3, 2006 4. Description of Device The Caldera Desara Mesh is sterile, single-use pubourethral sling used to provide suppor…	Herniamesh S.R.L.	2006	—

Also cleared against K050516: 1 other device →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101169	Desara Mesh Model: Cal-DS01	Caldera Medical, Inc.	2010	5
K083471	GMD Universal Sling, Model Product Code 1010 and 1020	Generic Medical Device, Inc.	2009	3
K101440	GMD Universal Urinary Incontinence Sling, Model 1012	Generic Medical Devices, Inc.	2010	1
K103022	KIM	Neomedic International S.L.	2011	0

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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K101169 (Caldera Medical, Inc., 2010) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K050516.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OTN

1in 2023

2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2007high 100 (2008) · low 25 (2010)2026

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

Recalls per year · OTN

1in 2014

2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · OTN

458in 2025

2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, 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	2	—	0	0
2008	3	100	0	0
2009	2	—	0	0
2010	5	25	0	1
2011	4	56	0	25
2012	1	—	0	874
2013	5	86	0	19,084
2014	1	—	1	2,063
2015	0	—	0	3,904
2016	0	—	0	1,902
2017	1	—	0	676
2018	0	—	0	737
2019	1	—	0	2,457
2020	1	—	0	1,003
2021	3	89	0	2,606
2022	2	—	0	809
2023	1	—	0	1,076
2024	0	—	0	822
2025	0	—	0	458
2026	1	—	0	—

What is it indicated for?

The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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/K072456 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072456: Desara Mesh Sling, Model Cal-DS01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072456

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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