510(k) Report

510(k) · Cleared

Recalled · 2009

A-Dec Decade 1020 Chair

K913535510(k) TraditionalCleared Oct 9, 199161-day reviewClass I21 CFR 872.6250Recalls 1

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

A-Dec, Inc. · KLC Chair, Dental, With Operative Unit

Cleared on Oct 9, 1991 after a 61-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided
Oct 9, 1991
Review
61 days
Class
Class I
Product code
KLC
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K913535Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 KLC? 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 KLC device

  1. #1 K233921 Luvis Chair (LC700C)score 11.9 · 4 generations · 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 1, 2009Not classifiedZ-0541-2011Device DesignThe design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KLC devices

KLC Chair, Dental, With Operative Unit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLC

1in 2024

2007: 12016: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLC

Too few KLC 510(k)s in any year since 2007 to give a median.

Recalls per year · KLC

6in 2010

2009: 12010: 6
2007high 6 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KLC

1in 2022

2007: 12008: 22009: 12010: 12011: 72012: 12013: 12014: 22015: 12022: 1
2007high 7 (2011) · low 0 (2016)2025

MAUDE reports naming product code KLC, 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
20071—01
20080—02
20090—11
20100—61
20110—07
20120—01
20130—01
20140—02
20150—01
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20241—00
20250—00
20260—0—
Cite this page

510(k) Report. “K913535: A-Dec Decade 1020 Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913535

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026