510(k) · Cleared
ClearedBlossom Saline Delivery Assist Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marz Medical, Inc. · LCJ Tissue Expander And Accessories
Cleared on Jul 10, 2014 as substantially equivalent to K853014 (Mcghan Medical Corp., 1985) after a 395-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jul 10, 2014
- Review
- 395 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853014 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK853014 Mcghan Tissue Expander Fill KitMcghan Medical Corp. · 1985 · Recalled
- This deviceK131692 Blossom Saline Delivery Assist DeviceMarz Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853014 | Mcghan Tissue Expander Fill Kit | Mcghan Medical Corp. | 1985 | 1 |
| 0 (this device) | K131692 | Blossom Saline Delivery Assist Device | Marz Medical, Inc. | 2014 | — |
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 LCJ? 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 LCJ device
- #1 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K853014 | Mcghan Tissue Expander Fill KitSummary page 1…Tissue Expander Accessory Predicate Device The Marz Blossom Syringe Accessory System is substantially equivalent to its predicate McGhan Tissue expander Fill Kit (K853014) commercially available via the FDA 510(k) Pre- Market Notification with regards to intended use, design, materials and technolog… | 1985 |
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?
- Its one ancestor has a recall.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LCJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCJ
525in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCJ
496in 2025
MAUDE reports naming product code LCJ, 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 | 10 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 58 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 31 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 3 | 256 | 0 | 20 |
| 2015 | 2 | — | 0 | 13 |
| 2016 | 3 | 153 | 0 | 38 |
| 2017 | 0 | — | 0 | 111 |
| 2018 | 3 | 29 | 0 | 518 |
| 2019 | 0 | — | 0 | 554 |
| 2020 | 0 | — | 0 | 639 |
| 2021 | 0 | — | 0 | 440 |
| 2022 | 0 | — | 0 | 499 |
| 2023 | 3 | 525 | 1 | 473 |
| 2024 | 1 | — | 0 | 488 |
| 2025 | 2 | — | 0 | 496 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Marz Blossom Syringe Assist device is intended to be used to assist the clinician in the delivery of sterile saline to fill temporary, removable tissue expanders in accordance with the best judgment of the clinician. Specifically, the Marz Blossom Syringe Assist device is indicated for assisting the clinician in delivery of sterile saline into the surgically placed sub-dermal temporary, removable tissue expander.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131692: Blossom Saline Delivery Assist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131692
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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