510(k) · Cleared

Cleared

Imtec Bone Collector System

K973248510(k) TraditionalCleared Nov 19, 199782-day reviewClass I21 CFR 872.6640

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

Imtec Corp. · EHZ Evacuator, Oral Cavity

Cleared on Nov 19, 1997 as substantially equivalent to K971036 (Interpore Intl., 1997) after an 82-day review. Its family tree reaches back 2 generations to 1982.

Decided: Nov 19, 1997
Review: 82 days
Class: Class I
Product code: EHZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K822065 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK822065 Kam SuckerThe Anspach Effort, Inc. · 1982
1 generation backK971036 Odontit Autogenous Bone Collection DeviceInterpore Intl. · 1997
This deviceK973248 Imtec Bone Collector SystemImtec Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K822065	Kam Sucker	The Anspach Effort, Inc.	1982	—
−1	K971036	Odontit Autogenous Bone Collection Device	Interpore Intl.	1997	—
0 (this device)	K973248	Imtec Bone Collector System	Imtec Corp.	1997	—

FIG. 1 — Lineage of K973248, 1982–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in EHZ? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K971036	Odontit Autogenous Bone Collection Device Summary page 1 …Name: Suction Powered Oral Cavity Evacuator. Proprietary Name: IMTEC Bone Collector System. PREDICATE DEVICE: ODONTIT, The ODONTIT Autogeneous Bone Collection Device, K971036. DEVICE DESCRIPTION: The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in aug…	Interpore Intl.	1997	—

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.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All EHZ devices

EHZ Evacuator, Oral Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHZ

FDA has decided no EHZ device since 2007.

Median 510(k) review, days · EHZ

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

Recalls per year · EHZ

1in 2022

2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · EHZ

1in 2024

2007high 1 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	1
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	1
2019	—	0	0
2020	—	0	1
2021	—	0	1
2022	—	1	0
2023	—	0	1
2024	—	0	1
2025	—	0	0
2026	—	0	—

What is it indicated for?

The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973248 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973248: Imtec Bone Collector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973248

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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