510(k) Report

510(k) · Cleared

Cleared

Start Junior

K073512510(k) TraditionalCleared Jan 14, 200831-day reviewClass I21 CFR 890.3850

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

Otto Bock Healthcare LP · IOR Wheelchair, Mechanical

Cleared on Jan 14, 2008 after a 31-day review. The FDA summary names no predicate by number. 5 later devices descend from it.

Decided
Jan 14, 2008
Review
31 days
Class
Class I
Product code
IOR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared20052010201520202025
  1. This deviceK073512 Start JuniorOtto Bock Healthcare LP · 2008
  2. Descendant · cites it directly · 4 of its ownK082314 Bravoracer Pediatric Manual WheelchairOtto Bock Healthcare LP · 2008
  3. Descendant · 2 generations on · 3 of its ownK120501 Champ Champ TransitConvaid Products, Inc. · 2012
  4. Descendant · 3 generations on · 2 of its ownK140416 Trekker, Trekker TransitConvaid Products, Inc. · 2014
  5. Descendant · 4 generations on · 1 of its ownK171017 Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit…Convaid Products, LLC · 2017
  6. Descendant · 4 generations on · 0 of its ownK251886 EmpowerRide NAVIGATOREmpower Ride, LLC · 2026

Most influential descendants

Showing 5 of 5 · See all
  • K082314Bravoracer Pediatric Manual WheelchairOtto Bock Healthcare LP · 2008 · cites it directly4descendants
  • K120501Champ Champ TransitConvaid Products, Inc. · 2012 · 2 generations on3descendants
  • K140416Trekker, Trekker TransitConvaid Products, Inc. · 2014 · 3 generations on2descendants
  • K171017Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T…Convaid Products, LLC · 2017 · 4 generations on1descendant
  • K251886EmpowerRide NAVIGATOREmpower Ride, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073512Start JuniorOtto Bock Healthcare LP2008—
+1K082314Bravoracer Pediatric Manual WheelchairOtto Bock Healthcare LP2008—
+2K120501Champ Champ TransitConvaid Products, Inc.2012—
+3K140416Trekker, Trekker TransitConvaid Products, Inc.2014—
+4K171017Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T…Convaid Products, LLC2017—
+4K251886EmpowerRide NAVIGATOREmpower Ride, LLC2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201210
201410
201710
202610
FIG. 1 — Lineage of K073512, 2008–2026Source: 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), 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 IOR? 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 IOR device

  1. #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 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?

The FDA summary names no predicate by number.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K082314Bravoracer Pediatric Manual WheelchairOtto Bock Healthcare LP20084

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, K082314 (Otto Bock Healthcare LP, 2008) has gone furthest, with 4 descendants of its own.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007: 52008: 132009: 42010: 122011: 62012: 112013: 72014: 72015: 32016: 102017: 72018: 32019: 62020: 22021: 22022: 42023: 92024: 42025: 72026 (partial year): 17
2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007: 38 days median2008: 32 days median2009: 43 days median2010: 81 days median2011: 58 days median2012: 176 days median2013: 233 days median2014: 211 days median2015: 104 days median2016: 135 days median2017: 209 days median2018: 203 days median2019: 160 days median2022: 150 days median2023: 61 days median2024: 65 days median2025: 91 days median2026 (partial year): 103 days median
2007high 233 (2013) · low 32 (2008)2026

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

Recalls per year · IOR

1in 2021

2007: 12008: 32009: 22011: 62012: 32013: 32014: 32016: 12021: 1
2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · IOR

135in 2025

2007: 362008: 622009: 542010: 692011: 2322012: 1,2382013: 4,6742014: 5,0822015: 4,4722016: 1,8602017: 492018: 582019: 532020: 432021: 592022: 372023: 1652024: 1382025: 135
2007high 5,082 (2014) · low 36 (2007)2025

MAUDE reports naming product code IOR, 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
2007538136
20081332362
2009443254
20101281069
20116586232
20121117631,238
2013723334,674
2014721135,082
2015310404,472
20161013511,860
20177209049
20183203058
20196160053
20202—043
20212—159
20224150037
20239610165
20244650138
20257910135
2026171030—

What is it indicated for?

Children who are unable to walk or who have a walking impediment.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073512: Start Junior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073512

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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