510(k) · Cleared
ClearedKawasumi Laboratories Large Wing Sets with Antineedle Stick Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kawasumi Laboratories, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 25, 2008 as substantially equivalent to K932074 (Medisystems Corp., 1994) and 3 other predicates after a 67-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Jan 25, 2008
- Review
- 67 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K873421 (1987). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK873421 Kawasumi a.V. Fistula SetKawasumi Laboratories Co., Ltd. · 1987
- This deviceK073257 Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK102994 K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK172957 Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873421 | Kawasumi a.V. Fistula Set | Kawasumi Laboratories Co., Ltd. | 1987 | — |
| 0 (this device) | K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector | Kawasumi Laboratories, Inc. | 2008 | — |
| +1 | K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector | Kawasumi Laboratories, Inc. | 2010 | — |
| +1 | K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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? (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 |
|---|---|---|---|
| * | K932074 | Medisystems Apheresis Needle with GuardSummary page 1…atory Blood Drawing Kit 3. 5 10O(k) Number: K994323, Name: Kawasumi Laboratories Phlebotomy Set 3. Predicate Device: Medisyterns Mastergurd Arterial Venous Fistula Set (K932074), Kawasunii A.V. Fistula Set (K873421), Kawasumi Laboratory Blood Drawing Kit (K001 043), and Kawasurni Laboratorie… | 1994 |
| * | K873421 | Kawasumi a.V. Fistula SetSummary page 1…or that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal firom the patient. 1. 5 10(k) Number: K87342 1, Name: Kawasurni ANV. Fistula Set 2. 5 10(k) Number: KOO 1043, Namne: Kawasurni Laboratory Blood Drawing Kit 3. 5 10O(k) Number:… | 1987 |
| * | K001043 | Kawasumi Laboratory Blood Drawing KitSummary page 1…t 3. Predicate Device: Medisyterns Mastergurd Arterial Venous Fistula Set (K932074), Kawasunii A.V. Fistula Set (K873421), Kawasumi Laboratory Blood Drawing Kit (K001 043), and Kawasurni Laboratories Phlebotomy Set (K994323) 4. Description of the Device: The design of the three previously cl… | 2000 |
| * | K994323 | Kawasumi Laboratories Philebotomy SetSummary page 1…the patient. 1. 5 10(k) Number: K87342 1, Name: Kawasurni ANV. Fistula Set 2. 5 10(k) Number: KOO 1043, Namne: Kawasurni Laboratory Blood Drawing Kit 3. 5 10O(k) Number: K994323, Name: Kawasumi Laboratories Phlebotomy Set 3. Predicate Device: Medisyterns Mastergurd Arterial Venous Fistula Set (K932074), K… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
Name: Kawasumi A.V. Fistula Set Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery. Name: Kawasumi…
Read the full statement (228 words)
Name: Kawasumi A.V. Fistula Set
Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.
Name: Kawasumi Laboratory Blood Drawing Kit
Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.
Name: Kawasumi Laboratories Phlebotomy Set
Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injures when the device is activated during removal from the patient's vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073257
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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