510(k) Report

510(k) · Cleared

Cleared

Mrinnervu (R) Endorectal Prostate Coil BPX-15

K926571510(k) TraditionalCleared Jul 20, 1993201-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

Medrad, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 20, 1993 after a 201-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided
Jul 20, 1993
Review
201 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared1997: 1 descendant cleared2025: 1 descendant cleared2006: 2 descendants cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK926571 Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc. · 1993
  2. Descendant · cites it directly · 5 of its ownK971380 Medrad Flex Interface DeviceMedrad, Inc. · 1997
  3. Descendant · cites it directly · 4 of its ownK051349 3.0T Prostate Imaging SystemMedrad, Inc. · 2005
  4. Descendant · 2 generations on · 1 of its ownK060401 Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006
  5. Descendant · 2 generations on · 0 of its ownK243428 e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems…Dxtx Medical, Inc. · 2025
  6. Descendant · 3 generations on · 0 of its ownK191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 12005: 12006: 22020: 12025: 1
1997high 2 (2006) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all
  • K971380Medrad Flex Interface DeviceMedrad, Inc. · 1997 · cites it directly5descendants
  • K0513493.0T Prostate Imaging SystemMedrad, Inc. · 2005 · cites it directly4descendants
  • K060401Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006 · 2 generations on1descendant
  • K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorDxtx Medical, Inc. · 2025 · 2 generations on0descendants
  • K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926571Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc.1993—
+1K971380Medrad Flex Interface DeviceMedrad, Inc.1997—
+1K0513493.0T Prostate Imaging SystemMedrad, Inc.2005—
+2K060401Medrad 3.0T Ecoil Imaging SystemMedrad, Inc.2006—
+2K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G…Dxtx Medical, Inc.2025—
+3K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200510
200620
202010
202510
FIG. 1 — Lineage of K926571, 1993–2025Source: 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 LNH? 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 LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K971380Medrad Flex Interface DeviceMedrad, Inc.19975
K0513493.0T Prostate Imaging SystemMedrad, Inc.20054

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, K971380 (Medrad, Inc., 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

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The LNH category page

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https://510kreport.com/device/K926571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926571: Mrinnervu (R) Endorectal Prostate Coil BPX-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926571

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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