510(k) Report

510(k) · Cleared

Cleared

Millar Mikro-Tip Catheter Pressure Transducer

K883651510(k) TraditionalCleared Nov 18, 198884-day reviewClass II21 CFR 870.1200

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

Millar Instruments, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Nov 18, 1988 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Nov 18, 1988
Review
84 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2015: 2 descendants cleared2013: 2 descendants cleared2019: 3 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK883651 Millar Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1988
  2. Descendant · cites it directly · 13 of its ownK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
  3. Descendant · 2 generations on · 8 of its ownK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
  4. Descendant · 3 generations on · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
  5. Descendant · 4 generations on · 2 of its ownK140466 Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile…St. Jude Medical Systems AB · 2014
  6. Descendant · 2 generations on · 2 of its ownK111201 C7 XR Imaging SystemLightlab Imaging, Inc. · 2011

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22012: 12013: 22014: 12015: 22016: 12018: 12019: 3
2008high 3 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008 · cites it directly13descendants
  • K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012 · 2 generations on8descendants
  • K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · 3 generations on7descendants
  • K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 2014 · 4 generations on2descendants
  • K111201C7 XR Imaging SystemLightlab Imaging, Inc. · 2011 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K883651Millar Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc.1988—
+1K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB2008—
+2K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical2012—
+3K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB2013—
+4K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus…St. Jude Medical Systems AB2014—
+2K111201C7 XR Imaging SystemLightlab Imaging, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201210
201320
201410
201520
201610
201810
201930
FIG. 1 — Lineage of K883651, 1988–2019Source: 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.

Planning a device in DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813

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?

  • Of its descendants, K080813 (Radi Medical Systems AB, 2008) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

More from Millar Instruments, Inc.

18 FDA decisions under this applicant name. See the company

  • K112323Cardia-CathMillar Instruments, Inc. · 2011
  • K093111Mikro-Cath, Model 825-0101Millar Instruments, Inc. · 2010
  • K013205Millar Pressure Control Unit Model Pcu-2000Millar Instruments, Inc. · 2002
  • K993694Mikro-Tip Angiographic CatheterMillar Instruments, Inc. · 20003 recalls
  • K952773Mikro-Tip Angiographic CatheterMillar Instruments, Inc. · 19952 recalls

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K883651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K883651: Millar Mikro-Tip Catheter Pressure Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883651

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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