510(k) · Cleared
ClearedBioaccess Marrow Harvest System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioaccess, Inc. · GDM Needle, Aspiration And Injection, Reusable
Cleared on Jun 3, 1997 as substantially equivalent to K953064 (Bioaccess, Inc., 1995) and 2 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jun 3, 1997
- Review
- 69 days
- Class
- Class I
- Product code
- GDM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K843830 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK843830 J -Jamshidi Type-Bone Marrow Biopsy/AspiPopper & Sons, Inc. · 1984
- This deviceK971114 Bioaccess Marrow Harvest SystemBioaccess, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843830 | J -Jamshidi Type-Bone Marrow Biopsy/Aspi | Popper & Sons, Inc. | 1984 | — |
| 0 (this device) | K971114 | Bioaccess Marrow Harvest System | Bioaccess, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 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 GDM? 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? (4)
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 |
|---|---|---|---|
| * | K953064 | Bioaccess Marrow Harvest SystemSummary page 1…nstrument motors and accessories/attachments. Marrow Harvest aspiration needle or trephine BioAccess Marrow Harvest System . BioAccess Bone Marrow Harvest Kit - 510(k) K953064 - never commercially distributed by BioAccess, Inc. . Jamshiti Aspiration needle - a pre-1976 device commercially distributed by… | 1995 |
| * | K843830 | J -Jamshidi Type-Bone Marrow Biopsy/AspiSummary page 1…needle - a pre-1976 device commercially distributed by Pharmaseal division of Baxter International. . Disposable "J" Type Bone Marrow Biopsy/Aspiration Needle - 510(k) K843830 - commercially distributed by Popper & Sons. Inc. . Hall Versipower Surgical Instrument System - 510(k) K895198 - know as the CO… | 1984 |
| * | K895198 | Hall Versipower Surgical Instrument SystemSummary page 1…e "J" Type Bone Marrow Biopsy/Aspiration Needle - 510(k) K843830 - commercially distributed by Popper & Sons. Inc. . Hall Versipower Surgical Instrument System - 510(k) K895198 - know as the CORB System formerly commercially distributed by Zimmer, Inc., discontinued due to poor sales performance. The dev… | 1989 |
| * | — | Jamshidi Aspiration needle Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K953064.
How does its category compare?
All GDM devicesGDM Needle, Aspiration And Injection, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDM
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GDM
Too few GDM 510(k)s in any year since 2007 to give a median.
Recalls per year · GDM
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDM
5in 2025
MAUDE reports naming product code GDM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 2 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
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/K971114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971114: Bioaccess Marrow Harvest System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971114
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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