510(k) Report

510(k) · Cleared

Cleared

Modification to Flow 7000 Peripheral Vascular Coil

K010730510(k) TraditionalCleared May 16, 200165-day reviewClass II21 CFR 892.1000

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

Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on May 16, 2001 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
May 16, 2001
Review
65 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2003: 2 descendants cleared200020052010201520202025
  1. This deviceK010730 Modification to Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 2001
  2. Descendant · cites it directly · 2 of its ownK023650 Insight Plus 9000 Phased Array Torso and Plevis CoilUsa Instruments, Inc. · 2003
  3. Descendant · 2 generations on · 1 of its ownK031172 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
  4. Descendant · cites it directly · 0 of its ownK042207 11000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004
  5. Descendant · 3 generations on · 0 of its ownK033490 Spirit 5000 Cardiac CoilUsa Instruments, Inc. · 2004

Most influential descendants

Showing 4 of 4 · See all
  • K023650Insight Plus 9000 Phased Array Torso and Plevis CoilUsa Instruments, Inc. · 2003 · cites it directly2descendants
  • K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003 · 2 generations on1descendant
  • K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004 · cites it directly0descendants
  • K033490Spirit 5000 Cardiac CoilUsa Instruments, Inc. · 2004 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010730Modification to Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc.2001—
+1K023650Insight Plus 9000 Phased Array Torso and Plevis CoilUsa Instruments, Inc.2003—
+2K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc.2003—
+1K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc.2004—
+3K033490Spirit 5000 Cardiac CoilUsa Instruments, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200420
FIG. 1 — Lineage of K010730, 2001–2004Source: 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 MOS? 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 MOS device

  1. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (4)

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

NumberDeviceApplicantDecidedDescendants
K023650Insight Plus 9000 Phased Array Torso and Plevis CoilUsa Instruments, Inc.20032
K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc.20040

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, K023650 (Usa Instruments, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

More from Usa Instruments, Inc.

64 FDA decisions under this applicant name. See the company

  • K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 20051 recall
  • K0526211.5T 16 Channel Brain-Spine Array CoilUsa Instruments, Inc. · 20051 recall
  • K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
  • K0525853T HD Breast ArrayUsa Instruments, Inc. · 20055 recalls
  • K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005

Recent decisions in MOS

The MOS category page

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  • K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS…Philips Medical Systems Nederland B.V. · 2026
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  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K010730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010730: Modification to Flow 7000 Peripheral Vascular Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010730

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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