510(k) · Cleared

Recalled · Class II · 2016

Endotine Transbleph 3.0/3.5 Device

K042796510(k) SpecialCleared Nov 5, 200429-day reviewClass II21 CFR 888.3040Recalls 1

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

Coapt Systems, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 5, 2004 as substantially equivalent to K040740 (Coapt Systems, Inc., 2004) and 3 other predicates after a 29-day review. Its family tree reaches back 4 generations to 2002. It has been recalled once.

Decided: Nov 5, 2004
Review: 29 days
Class: Class II
Product code: HWC
Recalls: 1
Predicates: 4

Its longest line of descent runs back 4 generations to K014153 (2002). 5 ancestors in all, the oldest K974309 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
3 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
2 generations backK033524 Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc. · 2003
1 generation backK040740 Endotine Transbleph DeviceCoapt Systems, Inc. · 2004
This deviceK042796 Endotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K014153	Coapt Systmes Endotine Device	Coapt Systems, Inc.	2002	—
−3	K023922	Coapt Systems Endotine Device, Model CFD-101-00197	Coapt Systems, Inc.	2002	—
−2	K033524	Coapt Endotine Chin 3.5 Device	Coapt Systems, Inc.	2003	—
−1	K040740	Endotine Transbleph Device	Coapt Systems, Inc.	2004	—
0 (this device)	K042796	Endotine Transbleph 3.0/3.5 Device	Coapt Systems, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K042796, 2002–2004Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (4)

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
*	K040740	Endotine Transbleph Device Summary page 2 …PMA Number ENDOTINE Coapt Systems, Inc K040740 TransBlephTM Device ENDOTINE Forehead TM Coapt Systems, Inc. K014153 Devices…	Coapt Systems, Inc.	2004	—
*	K014153	Coapt Systmes Endotine Device Summary page 2 …ENDOTINE Coapt Systems, Inc K040740 TransBlephTM Device ENDOTINE Forehead TM Coapt Systems, Inc. K014153 Devices K023992 ENDOTINE ChinTM Coapt Systems, I…	Coapt Systems, Inc.	2002	—
*	K023922	Coapt Systems Endotine Device, Model CFD-101-00197 Our reading of the summary gave K023992, FDA’s number for Wiener Lab Colinesterasa AA (Wiener Laboratories Saic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ENDOTINE Forehead Devices”.	Coapt Systems, Inc.	2002	—
*	K033524	Coapt Endotine Chin 3.5 Device Summary page 2 …K014153 Devices K023992 ENDOTINE ChinTM Coapt Systems, Inc. K033524 Devices DEVICE DESCRIPTION The ENDOTINE TransBleph TM 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool,…	Coapt Systems, Inc.	2003	—

Also cleared against K040740: 1 other 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
May 6, 2016	Class II	Z-2294-2016	Labeling Change Control	MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 9 months on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K040740.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The ENDOTINE TransBleph is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042796: Endotine Transbleph 3.0/3.5 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042796

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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