510(k) · Cleared
ClearedOdontit Autogenous Bone Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Intl. · GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Cleared on Jun 3, 1997 as substantially equivalent to K822065 (The Anspach Effort, Inc., 1982) after a 75-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Jun 3, 1997
- Review
- 75 days
- Class
- Class I
- Product code
- GCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822065 (1982). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K973248Imtec Bone Collector SystemImtec Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822065 | Kam Sucker | The Anspach Effort, Inc. | 1982 | — |
| 0 (this device) | K971036 | Odontit Autogenous Bone Collection Device | Interpore Intl. | 1997 | — |
| +1 | K973248 | Imtec Bone Collector System | Imtec Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
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 GCY? 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
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 | Decided |
|---|---|---|---|
| * | K822065 | Kam SuckerSummary page 1…on Apparatus Common/Usual Name: Disposable Aspirator Proprietary Name: Odontit Autogenous Bone Collection Device PREDICATE DEVICE KAM Super Sucker™ [reference 510(k) K822065 cleared 8/16/82] DEVICE DESCRIPTION The Odontit Autogenous Bone Collection Device is a portable suction device intended for use… | 1982 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973248 | Imtec Bone Collector System | 1997 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K973248 (Imtec Corp., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCY devicesGCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCY
FDA has decided no GCY device since 2007.
Median 510(k) review, days · GCY
Too few GCY 510(k)s in any year since 2007 to give a median.
Recalls per year · GCY
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCY
178in 2025
MAUDE reports naming product code GCY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 246 |
| 2008 | 0 | — | 38 | 205 |
| 2009 | 0 | — | 2 | 231 |
| 2010 | 0 | — | 1 | 124 |
| 2011 | 0 | — | 12 | 58 |
| 2012 | 0 | — | 0 | 47 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 145 |
| 2017 | 0 | — | 0 | 260 |
| 2018 | 0 | — | 1 | 180 |
| 2019 | 0 | — | 0 | 200 |
| 2020 | 0 | — | 0 | 202 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 96 |
| 2023 | 0 | — | 0 | 90 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
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/K971036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971036: Odontit Autogenous Bone Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971036
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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