510(k) · Cleared
ClearedLockbox for Use with Medfusion 3000 Series Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Jun 12, 2009 as substantially equivalent to K080743 (Smiths Medical MD, Inc., 2008) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 12, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942161 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942161 | Lockbox | Pharmacia Deltec, Inc. | 1994 | — |
| 0 (this device) | K091181 | Lockbox for Use with Medfusion 3000 Series Pumps | Smiths Medical MD, Inc. | 2009 | — |
| +1 | K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K080743 | Lockbox for Use with Cadd Solis Infusion PumpSummary page 1…ation: 21 CFR §880.5725 Predicate Device(s) The predicate devices are the currently marketed LockBox for use with the CADDO-Solis Ambulatory Infusion Pump (K080743) and LockBox with Syringe Holder (K942161). Device Description The Lockbox is an accessory to the MedfusionTm 3000 Series Syring… | 2008 |
| * | K942161 | LockboxSummary page 1…icate Device(s) The predicate devices are the currently marketed LockBox for use with the CADDO-Solis Ambulatory Infusion Pump (K080743) and LockBox with Syringe Holder (K942161). Device Description The Lockbox is an accessory to the MedfusionTm 3000 Series Syringe Pump. It is a lockable, plastic enclosur… | 1994 |
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 |
|---|---|---|---|
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | 2018 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K173531 (B.Braun Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lockbox is intended to hold a MedfusionTM 3000 Series Pump and provide reasonably secure access to the medication syringe contained within.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091181: Lockbox for Use with Medfusion 3000 Series Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091181
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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