510(k) · Cleared
ClearedMechanical Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novaf Andalucia 2007, SL · IQC Wheelchair, Special Grade
Cleared on Jul 6, 2012 as substantially equivalent to K031910 (Db Perks & Associates, Ltd., 2003) and 2 other predicates after a 156-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jul 6, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- IQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915262 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK915262 Bantex Brand WheelchairsBantex Corp. · 1992
- 3 generations backK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
- 2 generations backK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
- 1 generation backK051709 Hippocampe WheelchairVipamat Technologie · 2005
- This deviceK120302 Mechanical WheelchairNovaf Andalucia 2007, SL · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915262 | Bantex Brand Wheelchairs | Bantex Corp. | 1992 | — |
| −3 | K982607 | Manual Wheelchair | G. Hirsch and Co., Inc. | 1998 | — |
| −2 | K031910 | Stainless Steel Aquatic Wheelchair | Db Perks & Associates, Ltd. | 2003 | — |
| −1 | K051709 | Hippocampe Wheelchair | Vipamat Technologie | 2005 | — |
| 0 (this device) | K120302 | Mechanical Wheelchair | Novaf Andalucia 2007, SL | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
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 IQC? 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 IQC device
- #1 K251570 Hippocampe Marathon and Trailscore 10.5 · 4 generations · no Class I recall
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031910 | Stainless Steel Aquatic WheelchairSummary page 1…Device. Name: Mechanical Chair Models: Oceanic/Oceanic Baby PREDICATE DEVICES: DB Perks and Associates Steel Aquatic Chair K031 910 Landeez All-Terrain Sport Chair K954261 Vipamat Technologie Hippocampe Wheelchair K051… | 2003 |
| * | K954261 | Landeez All-Terrain WheelchairSummary page 1…Oceanic/Oceanic Baby PREDICATE DEVICES: DB Perks and Associates Steel Aquatic Chair K031 910 Landeez All-Terrain Sport Chair K954261 Vipamat Technologie Hippocampe Wheelchair K051 709 FDA PRODUCT CODE: O0C FDA CLASSIFICATION: Clas… | 1995 |
| * | K051709 | Hippocampe WheelchairSummary page 1…ates Steel Aquatic Chair K031 910 Landeez All-Terrain Sport Chair K954261 Vipamat Technologie Hippocampe Wheelchair K051 709 FDA PRODUCT CODE: O0C FDA CLASSIFICATION: Class 11 PANEL CODE: Physical Medicine REGULATION NUMBER:… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K031910.
How does its category compare?
All IQC devicesIQC Wheelchair, Special Grade: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IQC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IQC
Too few IQC 510(k)s in any year since 2007 to give a median.
Recalls per year · IQC
No recall names IQC since 2007.
Adverse event reports per year · IQC
No MAUDE report names IQC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oceanic is a manual attendlant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120302: Mechanical Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120302
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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