510(k) · Cleared
ClearedJohnson & Johnson Sterile Spray Tip Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Patient Care, Inc. · KYZ Syringe, Irrigating (Non Dental)
Cleared on Dec 15, 1988 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.
- Decided
- Dec 15, 1988
- Review
- 31 days
- Class
- Class I
- Product code
- KYZ
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 1 citing it directly.
- This deviceK884749 Johnson & Johnson Sterile Spray Tip SyringeJohnson & Johnson Patient Care, Inc. · 1988
- Descendant · cites it directly · 36 of its ownK050797 Tissu-TransShippert Medical Technologies Corp. · 2005
- Descendant · 2 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · 2 generations on · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
- Descendant · 2 generations on · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K050797Tissu-TransShippert Medical Technologies Corp. · 2005 · cites it directly36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 2 generations on34descendants
- K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · 2 generations on17descendants
- K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · 2 generations on12descendants
- K120902GID 700The Gid Group, Inc. · 2012 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884749 | Johnson & Johnson Sterile Spray Tip Syringe | Johnson & Johnson Patient Care, Inc. | 1988 | — |
| +1 | K050797 | Tissu-Trans | Shippert Medical Technologies Corp. | 2005 | — |
| +2 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +2 | K092482 | Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 | Shippert Medical Technologies Corp. | 2009 | 8 |
| +2 | K081848 | Lipose Fat Transfer System | Lipose Corp. | 2008 | — |
| +3 | K120902 | GID 700 | The Gid Group, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
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 KYZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050797 | Tissu-Trans | 2005 | 36 |
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, K050797 (Shippert Medical Technologies Corp., 2005) has gone furthest, with 36 descendants of its own.
How does its category compare?
All KYZ devicesKYZ Syringe, Irrigating (Non Dental): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KYZ
Too few KYZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KYZ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KYZ
28in 2025
MAUDE reports naming product code KYZ, 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 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 2 |
| 2011 | 1 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 5 | 8 |
| 2017 | 0 | — | 0 | 52 |
| 2018 | 0 | — | 1 | 76 |
| 2019 | 0 | — | 0 | 69 |
| 2020 | 1 | — | 0 | 88 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 1 (1) | 14 |
| 2024 | 0 | — | 0 | 106 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K884749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884749: Johnson & Johnson Sterile Spray Tip Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884749
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026