510(k) Report

510(k) · Cleared

Cleared

Ride-Lite 9000 Series Wheelchair

K881951510(k) TraditionalCleared May 19, 19889-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

Invacare Corp. · IOR Wheelchair, Mechanical

Cleared on May 19, 1988 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
May 19, 1988
Review
9 days
Class
Class I
Product code
IOR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK881951 Ride-Lite 9000 Series WheelchairInvacare Corp. · 1988
  2. Descendant · cites it directly · 1 of its ownK061273 7000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200LNova Ortho-Med, Inc. · 2006
  3. Descendant · 2 generations on · 0 of its ownK131529 Shengguang Manual WheelchairPingdingshan Shenxing Healthcare Technology Co., L · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K0612737000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200LNova Ortho-Med, Inc. · 2006 · cites it directly1descendant
  • K131529Shengguang Manual WheelchairPingdingshan Shenxing Healthcare Technology Co., L · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881951Ride-Lite 9000 Series WheelchairInvacare Corp.1988—
+1K0612737000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200LNova Ortho-Med, Inc.2006—
+2K131529Shengguang Manual WheelchairPingdingshan Shenxing Healthcare Technology Co., L2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201310
FIG. 1 — Lineage of K881951, 1988–2013Source: 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 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
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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? (2)

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

NumberDeviceApplicantDecidedDescendants
K0612737000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200LNova Ortho-Med, Inc.20061

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, K061273 (Nova Ortho-Med, Inc., 2006) has gone furthest, with 1 descendant 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.

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—
Cite this page

510(k) Report. “K881951: Ride-Lite 9000 Series Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881951

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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