510(k) Report

510(k) · Cleared

Cleared

Tilt Adjustable Sliding Back Recline Seating Syst

K923364510(k) TraditionalCleared Mar 22, 1993257-day reviewClass I21 CFR 890.3920

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

Labac Systems, Inc. · KNN Components, Wheelchair

Cleared on Mar 22, 1993 after a 257-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Mar 22, 1993
Review
257 days
Class
Class I
Product code
KNN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared1990200020102020
  1. This deviceK923364 Tilt Adjustable Sliding Back Recline Seating SystLabac Systems, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK211919 KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923364Tilt Adjustable Sliding Back Recline Seating SystLabac Systems, Inc.1993—
+1K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K923364, 1993–2022Source: 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 KNN? 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 KNN device

  1. #1 K211919 KISS Dynamic Back Support, KISS Dynamic Solid…score 3.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC20220

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, K211919 (Kinetic Innovative Seating System, LLC, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KNN devices

KNN Components, Wheelchair: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNN

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

2012: 12023: 12026 (partial year): 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KNN

10in 2025

2007: 32008: 12009: 12010: 12011: 12012: 282013: 772014: 642015: 42016: 22017: 32018: 42019: 22020: 12021: 162022: 32023: 22024: 42025: 10
2007high 77 (2013) · low 1 (2008)2025

MAUDE reports naming product code KNN, 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
20070—03
20080—01
20090—01
20100—01
20110—01
20120—128
20130—077
20140—064
20150—04
20160—02
20170—03
20180—04
20190—02
20200—01
20210—016
20221—03
20230—12
20240—04
20250—010
20260—1—
Cite this page

510(k) Report. “K923364: Tilt Adjustable Sliding Back Recline Seating Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923364

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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