510(k) Report

510(k) · Cleared

Cleared

Palm Bladder Scanner

K130229510(k) AbbreviatedCleared Mar 20, 201350-day reviewClass II21 CFR 892.1560

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

Mianyang Meike Electronic Equipment Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Mar 20, 2013 as substantially equivalent to K071217 (Verathon Incorporated, 2007) after a 50-day review. Its family tree reaches back 4 generations to 1992. 7 later devices descend from it.

Decided
Mar 20, 2013
Review
50 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K915436 (1992). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 1 other ancestor2019: 1 descendant cleared2018: 1 descendant cleared2022: 3 descendants cleared2026: 1 descendant cleared2021: 1 descendant clearedK915436 · Bladderscan Bvi 2500 · Diagnostic Ultrasound Corp. · 1992K955840 · Bladdermanager Pci 5000 / Bladderscan Bvi 5000 · Diagnostic Ultrasound Corp. · 1996K022153 · Bladderscan Bvi 6100 · Diagnostic Ultrasound Corp. · 2002 · recalledK071217 · Bladderscan Bvi 9400 Ultrasound · Verathon Incorporated · 2007 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants K071217 · Bladderscan Bvi 9400 Ultrasound · Verathon Incorporated · 2007 · recalledK022153 · Bladderscan Bvi 6100 · Diagnostic Ultrasound Corp. · 2002 · recalledK955840 · Bladdermanager Pci 5000 / Bladderscan Bvi 5000 · Diagnostic Ultrasound Corp. · 1996K915436 · Bladderscan Bvi 2500 · Diagnostic Ultrasound Corp. · 19920
  1. Root · 4 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
  2. 3 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
  3. 2 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
  4. 1 generation backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
  5. This deviceK130229 Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013
  6. Descendant · cites it directly · 4 of its ownK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
  7. Descendant · 2 generations on · 1 of its ownK211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C…Guangzhou Sonostar Technologies Co., Ltd. · 2022
  8. Descendant · cites it directly · 1 of its ownK191307 Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. · 2019
  9. Descendant · 2 generations on · 0 of its ownK260111 Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026
  10. Descendant · 2 generations on · 0 of its ownK220169 SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C…Bionet Co., Ltd. · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12021: 12022: 32026: 1
2018high 3 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd. · 2018 · cites it directly4descendants
  • K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd. · 2022 · 2 generations on1descendant
  • K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. · 2019 · cites it directly1descendant
  • K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026 · 2 generations on0descendants
  • K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K915436Bladderscan Bvi 2500Diagnostic Ultrasound Corp.1992—
−3K955840Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp.1996—
−2K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp.20021
−1K071217Bladderscan Bvi 9400 UltrasoundVerathon Incorporated20071
0 (this device)K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd.2013—
+1K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.2018—
+2K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L…Guangzhou Sonostar Technologies Co., Ltd.2022—
+1K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd.2019—
+2K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.2026—
+2K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L…Bionet Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202110
202230
202610
FIG. 1 — Lineage of K130229, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K071217Bladderscan Bvi 9400 Ultrasound
Summary page 1
…* Regulation Number 892.1570 * Product Code: [TX ' Predicate Device: Verathon BladderScan®&BVI 9400 Ultrasound System (K071217) ' Device Description Palm bladder scanner is a medical device with high performance combined with modern B-mode ultrasound te…
Verathon Incorporated20071

Also cleared against K071217: 11 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184
K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd.20191

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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K172750 (Guangzhou Sonostar Technologies Co., Ltd., 2018) has gone furthest, with 4 descendants of its own.
  • 11 other devices also cite its predicate K071217.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

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

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

Abdomen, B-Mode, per Indications for Use Ultrasound Form

PBSV4. I bladder scanner is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively.

Indications for use as stated in the FDA summary.

Also cleared against K071217

11 other devices cite the same predicate.

  • K170046Lilium a-200ELilium Otsuka Co., Ltd. · 2017
  • K160420SpeqTSignostics Limited · 2016
  • K153101BladderScan Prime SystemVerathon Incorporated · 2015
  • K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
  • K121689Vitascan LT ScanmasterVitacon Medical, Inc. · 2012
  • K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011

More from Mianyang Meike Electronic Equipment…

3 FDA decisions under this applicant name. See the company

  • K210591Palm Bladder Scanner - PBSV7.1Mianyang Meike Electronic Equipment Co., Ltd. · 2021
  • K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. · 2019

Recent decisions in IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K130229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130229: Palm Bladder Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130229

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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