PDS-2000

K902653510(k) TraditionalCleared Sep 13, 199090-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

Intl. Equipment and Supply Corp. · EIK Carver, Wax, Dental

Cleared on Sep 13, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Sep 13, 1990
Review: 90 days
Class: Class I
Product code: EIK
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K902653Source: FDA 510(k) database · How lineage is built

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 EIK? 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

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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 EIK devices

EIK Carver, Wax, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIK

FDA has decided no EIK device since 2007.

Median 510(k) review, days · EIK

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

Recalls per year · EIK

No recall names EIK since 2007.

Adverse event reports per year · EIK

No MAUDE report names EIK since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K902653 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902653: PDS-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902653

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Record history

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