510(k) Report

510(k) · Cleared

Cleared

Sunbeam Dental Care Center, Model NO. 6273

K852593510(k) TraditionalCleared Jul 24, 198535-day reviewClass I21 CFR 872.6510

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

Northern Electric Co. Div. of Sunbeam Corp. · EFS Unit, Oral Irrigation

Cleared on Jul 24, 1985 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 24, 1985
Review
35 days
Class
Class I
Product code
EFS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K852593Source: 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 EFS devices

EFS Unit, Oral Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFS

FDA has decided no EFS device since 2007.

Median 510(k) review, days · EFS

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

Recalls per year · EFS

No recall names EFS since 2007.

Adverse event reports per year · EFS

9in 2025

2007: 12011: 12012: 22015: 72016: 62017: 72018: 132019: 62020: 162021: 182022: 212023: 342024: 312025: 9
2007high 34 (2023) · low 0 (2008)2025

MAUDE reports naming product code EFS, 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—01
20080—00
20090—00
20100—00
20110—01
20120—02
20130—00
20140—00
20150—07
20160—06
20170—07
20180—013
20190—06
20200—016
20210—018
20220—021
20230—034
20240—031
20250—09
20260—0—

More from Northern Electric Co. Div. of Sunbeam…

4 FDA decisions under this applicant name. See the company

  • K860118Sunbeam Ultrasonic Denture Cleaner Model 4220Northern Electric Co. Div. of Sunbeam Corp. · 1986
  • K851220Sunbeam Evaporative Humidifier 663 & 664Northern Electric Co. Div. of Sunbeam Corp. · 1985
  • K852279Sunbeam Rechargeable Toothbrush Model # 4201Northern Electric Co. Div. of Sunbeam Corp. · 1985

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  • K964810DermadamUltradent Products, Inc. · 1997
  • K952234Barrier All FilmCottrell, Ltd. · 1995

https://510kreport.com/device/K852593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K852593: Sunbeam Dental Care Center, Model NO. 6273.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K852593

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