510(k) · Cleared

Cleared

Perimetrics Periometer

K072213510(k) TraditionalCleared Aug 29, 2008386-day reviewClass I21 CFR 872.4200

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

Perimetrics, Inc. · EKX Handpiece, Direct Drive, Ac-Powered

Cleared on Aug 29, 2008 after a 386-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Aug 29, 2008
Review: 386 days
Class: Class I
Product code: EKX
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK072213 Perimetrics PeriometerPerimetrics, Inc. · 2008
Descendant · cites it directly · 1 of its ownK232657 InnerView LCPerimetrics, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK251597 InnerView SystemPerimetrics, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all

K232657InnerView LCPerimetrics, Inc. · 2023 · cites it directly1descendant
K251597InnerView SystemPerimetrics, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K072213	Perimetrics Periometer	Perimetrics, Inc.	2008	—
+1	K232657	InnerView LC	Perimetrics, Inc.	2023	—
+2	K251597	InnerView System	Perimetrics, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2025	1	0

FIG. 1 — Lineage of K072213, 2008–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKX? 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 EKX device

#1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K232657	InnerView LC	Perimetrics, Inc.	2023	1

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, K232657 (Perimetrics, Inc., 2023) has gone furthest, with 1 descendant of its own.

How does its category compare?

All EKX devices

EKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EKX

5in 2025

2007high 5 (2021) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EKX

244in 2025

2007high 359 (2022) · low 75 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EKX

No recall names EKX since 2007.

Adverse event reports per year · EKX

9in 2025

2007high 102 (2014) · low 6 (2011)2025

MAUDE reports naming product code EKX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	9
2008	3	101	10
2009	4	186	11
2010	3	114	20
2011	4	75	6
2012	2	—	27
2013	2	—	45
2014	3	251	102
2015	3	178	68
2016	3	274	66
2017	2	—	10
2018	3	293	49
2019	3	349	56
2020	1	—	67
2021	5	214	79
2022	3	359	37
2023	4	152	14
2024	4	276	19
2025	5	244	9
2026	1	—	—

What is it indicated for?

The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K072213 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072213: Perimetrics Periometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072213

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026