510(k) · Cleared

Cleared

BioZorb Marker GOLD / LP Marker GOLD

K171467510(k) TraditionalCleared Nov 9, 2017175-day reviewClass II21 CFR 892.5050

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

Focal Therapeutics · IYE Accelerator, Linear, Medical

Cleared on Nov 9, 2017 as substantially equivalent to K071614 (Civco, 2007) and 4 other predicates after a 175-day review. Its family tree reaches back 7 generations to 1995. 2 of the 26 devices in its family, counting itself, have a Class I recall.

Decided: Nov 9, 2017
Review: 175 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K935844 (1995). 25 ancestors in all, the oldest K934356 (1994). No later device cites it as a predicate yet. 2 of the 26 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
2 generations backK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
1 generation backK132708 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
This deviceK171467 BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics · 2017

Class I recalls in this family

K152070 BioZorb LP Markerdirect predicate · 2015
K143484 BioZorb Markerdirect predicate · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K935844	Gip/Medi-Globe Needle System for Ultrasonic Fna	Medi-Globe Corp.	1995	—
−6	K990220	Modification of Gip/Medi-Globe Ultrasound Needle System	Medi-Globe Corp.	1999	—
−5	K051247	Sonotip II Ultrasound Needle System	Medi-Globe Corp.	2005	—
−4	K070129	Sonotip II Ultrasound Needle System	Medi-Globe Corporation	2007	—
−3	K083330	Echotip Ultra Ultrasound Needle	Cook Endoscopy	2009	—
−2	K111895	Echotip (R) Ultra Fiducial Needle	Wilson-Cook Medical Inc./Cook Endoscopy	2012	—
−1	K132708	Biomarc Fiducial Marker	Carbon Medical Technologies, Inc.	2013	—
0 (this device)	K171467	BioZorb Marker GOLD / LP Marker GOLD	Focal Therapeutics	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2000	1	0
2001	2	0
2002	1	0
2003	2	0
2004	1	0
2006	1	0
2007	2	0
2008	1	0
2010	1	0
2011	2	0
2012	1	0
2015	2	2

FIG. 1 — Lineage of K171467, 1995–2017Source: 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.

2 devices in this family have a Class I recall. 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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? (5)

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
*	K071614	Fiducial Markers Summary page 4 …R 892.5050 NAME: DEVICE Class II CLASSIFICATION: PRODUCT CODE: IYE PREDICATE DEVICES: Civco Suture-type Marker (K071614) (Primary Predicate) Focal Therapeutics BioZorb Marker (K143484) and BioZorb LP Mar…	Civco	2007	2
*	K143484	BioZorb Marker Summary page 4 …PRODUCT CODE: IYE PREDICATE DEVICES: Civco Suture-type Marker (K071614) (Primary Predicate) Focal Therapeutics BioZorb Marker (K143484) and BioZorb LP Marker (K152070) BiomarC Fiducial Marker (K132708, K110772) Substa…	Focal Therapeutics	2015	Class I
*	K152070	BioZorb LP Marker Summary page 4 …: Civco Suture-type Marker (K071614) (Primary Predicate) Focal Therapeutics BioZorb Marker (K143484) and BioZorb LP Marker (K152070) BiomarC Fiducial Marker (K132708, K110772) Substantially Equivalent To: The BioZorb Marker GOLD/ LP Mark…	Focal Therapeutics	2015	Class I
*	K132708	Biomarc Fiducial Marker Summary page 4 …Focal Therapeutics BioZorb Marker (K143484) and BioZorb LP Marker (K152070) BiomarC Fiducial Marker (K132708, K110772) Substantially Equivalent To: The BioZorb Marker GOLD/ LP Marker GOLD is substantially equivalent in intended use, prin…	Carbon Medical Technologies, Inc.	2013	—
*	K110772	Biomarc Fiducial Marker Summary page 4 …Focal Therapeutics BioZorb Marker (K143484) and BioZorb LP Marker (K152070) BiomarC Fiducial Marker (K132708, K110772) Substantially Equivalent To: The BioZorb Marker GOLD/ LP Marker GOLD is substantially equivalent in intended use, principal of…	Carbon Medical Technologies, Inc.	2011	—

Also cleared against K071614: 10 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K152070BioZorb LP MarkerFocal Therapeutics · 2015 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
K143484BioZorb MarkerFocal Therapeutics · 2015 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
3 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
10 other devices also cite its predicate K071614.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171467 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171467: BioZorb Marker GOLD / LP Marker GOLD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171467

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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