510(k) Report

510(k) · Cleared

Cleared

Travenol Disposable Dental Scalers/Curettes

K854168510(k) TraditionalCleared Mar 13, 1986149-day reviewClass I21 CFR 872.4565

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

Travenol Laboratories, S.A. · ELA Instrument, Hand, Calculus Removal

Cleared on Mar 13, 1986 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 13, 1986
Review
149 days
Class
Class I
Product code
ELA
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K854168Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All ELA devices

ELA Instrument, Hand, Calculus Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELA

FDA has decided no ELA device since 2007.

Median 510(k) review, days · ELA

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

Recalls per year · ELA

No recall names ELA since 2007.

Adverse event reports per year · ELA

3in 2015

2015: 3
2007high 3 (2015) · low 0 (2007)2025

MAUDE reports naming product code ELA, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—03
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Travenol Laboratories, S.A.

206 FDA decisions under this applicant name. See the company

  • K874181Baxter Bedside SystemTravenol Laboratories, S.A. · 1988
  • K873894Continu-Flo Solution W/Check Valve 2 Y-Inject SiteTravenol Laboratories, S.A. · 1987
  • K873873Resubmitted Micron Transfusion FilterTravenol Laboratories, S.A. · 1987
  • K873984Automatic Peritoneal Dialysis Cycler Set (5C4437)Travenol Laboratories, S.A. · 1987
  • K872364Hemodialysis (SPS), Model 550, Code 5M1309Travenol Laboratories, S.A. · 19872 recalls

Recent decisions in ELA

The ELA category page

  • K952363Opus Pacemakers (Models 4021, 4033, and 4034)Ela Medical, Inc. · 1995
  • K823326Dental Instruments - Cutting InstrumentMiltex, Inc. · 1982
  • K801974Analytic Tech. Metal Point Heater #3001Analytic Technology · 1980

https://510kreport.com/device/K854168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K854168: Travenol Disposable Dental Scalers/Curettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854168

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