510(k) · Cleared
ClearedKISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Innovative Seating System, LLC · KNN Components, Wheelchair
Cleared on Mar 4, 2022 as substantially equivalent to K942312 (Lewis W. Ward, 1994) and 1 other predicate after a 256-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 4, 2022
- Review
- 256 days
- Class
- Class I
- Product code
- KNN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923364 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923364 Tilt Adjustable Sliding Back Recline Seating SystLabac Systems, Inc. · 1993
- This deviceK211919 KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923364 | Tilt Adjustable Sliding Back Recline Seating Syst | Labac Systems, Inc. | 1993 | — |
| 0 (this device) | K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | Kinetic Innovative Seating System, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 KNN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K942312 | Alden Lineage Wheelchair CushionSummary page 4…onent (21 CFR 890.3920, Product Code KNN) Legally marketed device compared for a determination of substantial equivalence: The KISS seat is substantially equivalent to K942312; product code KNN; device name, Alden Lineage Wheelchair Cushion. Both devices are wheelchair seating components, regulation numb… | 1994 |
| * | K923364 | Tilt Adjustable Sliding Back Recline Seating SystSummary page 5…person seated upright in a wheelchair. Both devices have a provision for suspension under the seat. The KISS back support is substantially equivalent to K923364; product code KNN; device name, Tilt Adjustable Back Recline Seating System by Labac Systems. Both devices are wheelchair seating… | 1993 |
| † | K982989 | Quickie Suspension Wheelchair Series Model XTR | 1998 |
| † | K123975 | Quickie & Zippie Series | 2013 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KNN devicesKNN Components, Wheelchair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KNN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KNN
Too few KNN 510(k)s in any year since 2007 to give a median.
Recalls per year · KNN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNN
10in 2025
MAUDE reports naming product code KNN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 77 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The KISS Dynamic Solid Drop Seat and Back Support devices are wheelchair components intended for medical purposes
that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part.
The KISS Dynamic Solid Drop Seat and Back Support are intended to assist posture and positioning for a person seated in
a wheelchair by way of providing a solid seating platform or back support with dynamic motion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211919: KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211919
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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