510(k) Report

510(k) · Cleared

Cleared

Zortran Detector

K000997510(k) TraditionalCleared Sep 7, 2000163-day reviewClass II21 CFR 880.5200

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

Lucent Medical Systems · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Sep 7, 2000 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 45 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.

Decided
Sep 7, 2000
Review
163 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

44 later devices descend from it, 1 citing it directly. 6 of the 45 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2006: 2 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2012: 3 descendants cleared, 1 with a Class I recall12014: 4 descendants cleared2017: 3 descendants cleared2015: 5 descendants cleared2013: 4 descendants cleared, 2 with a Class I recall22022: 2 descendants cleared2016: 4 descendants cleared, 3 with a Class I recall32018: 2 descendants cleared2025: 4 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK000997 Zortran DetectorLucent Medical Systems · 2000
  2. Descendant · cites it directly · 43 of its ownK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
  3. Descendant · 2 generations on · 42 of its ownK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
  5. Descendant · 3 generations on · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
  6. Descendant · 3 generations on · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2006: 22008: 22009: 12010: 22011: 32012: 32013: 42014: 42015: 52016: 42017: 32018: 22021: 12022: 22024: 12025: 42026: 1
2006high 5 (2015) · low 0 (2007)2026

Class I recalls in this family

  • K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet5 generations on · 2012
  • K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet5 generations on · 2013
  • K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet6 generations on · 2013
  • K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…6 generations on · 2016

Most influential descendants

Showing 5 of 44 · See all
  • K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006 · cites it directly43descendants
  • K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · 2 generations on42descendants
  • K081625Flowpicc StyletVasonova, Inc. · 2008 · 3 generations on40descendants
  • K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 3 generations on39descendants
  • K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc. · 2009 · 3 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000997Zortran DetectorLucent Medical Systems2000—
+1K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.2006—
+2K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.200618
+3K081625Flowpicc StyletVasonova, Inc.2008—
+3K081626Flowpicc ConsoleVasonova, Inc.2008—
+3K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.200911

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200820
200910
201020
201130
201231
201342
201440
201550
201643
201730
201820
202110
202220
202410
202540
202610
FIG. 1 — Lineage of K000997, 2000–2026Source: 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.

6 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (44)

See all 44

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.200643

Has anything in its family been recalled? (6 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.

  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
  • K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
  • K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • Of its descendants, K060341 (C.R. Bard, Inc., 2006) has gone furthest, with 43 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

More from Lucent Medical Systems

2 FDA decisions under this applicant name. See the company

  • K061240Sherlock Tip Location System (TLS) Detector and AccessoriesLucent Medical Systems · 2006

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K000997 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000997: Zortran Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000997

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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