510(k) Report

510(k) · Cleared

Cleared

Angel Wing Safety Blood Collection and Infusion SE

K912563510(k) TraditionalCleared Oct 2, 1991113-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mbo Laboratories, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Oct 2, 1991 after a 113-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 93 later devices descend from it.

Decided
Oct 2, 1991
Review
113 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

93 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2015: 3 descendants cleared2001: 2 descendants cleared2008: 8 descendants cleared2012: 4 descendants cleared2010: 3 descendants cleared2002: 3 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2017: 6 descendants cleared2004: 4 descendants cleared2007: 11 descendants cleared2009: 3 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2016: 1 descendant cleared2006: 1 descendant cleared2011: 5 descendants cleared2014: 3 descendants cleared2021: 4 descendants cleared2022: 1 descendant cleared2025: 7 descendants cleared2023: 4 descendants cleared2024: 2 descendants cleared2013: 6 descendants cleared2020: 2 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
  2. Descendant · cites it directly · 80 of its ownK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 70 of its ownK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
  4. Descendant · 3 generations on · 68 of its ownK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
  5. Descendant · 3 generations on · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
  6. Descendant · 4 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22002: 32003: 12004: 42005: 22006: 12007: 112008: 82009: 32010: 32011: 52012: 42013: 62014: 32015: 32016: 12017: 62018: 12019: 32020: 22021: 42022: 12023: 42024: 22025: 72026: 2
2000high 11 (2007) · low 1 (2000)2026

Most influential descendants

Showing 5 of 93 · See all
  • K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · cites it directly80descendants
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · 2 generations on70descendants
  • K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004 · 3 generations on68descendants
  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · 3 generations on67descendants
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 4 generations on66descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912563Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc.1991—
+1K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.20002
+2K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.20011
+3K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc.2004—
+3K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.20052
+4K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200230
200310
200440
200520
200610
2007110
200880
200930
201030
201150
201240
201360
201430
201530
201610
201760
201810
201930
202020
202140
202210
202340
202420
202570
202620
FIG. 1 — Lineage of K912563, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FOZ? 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (93)

See all 93

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.200080
K011786Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc.200110
K131950Angel Tip Safety Intravascular Needle SetSummit International Medical Technologies, Inc.20150

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, K993848 (Millennium Medical Distribution, Inc., 2000) has gone furthest, with 80 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

More from Mbo Laboratories, Inc.

3 FDA decisions under this applicant name. See the company

  • K922468Angel Wing Sets -- ModifiedMbo Laboratories, Inc. · 1992
  • K920184Angel Wing Safety Blood Collection with Tube Hold.Mbo Laboratories, Inc. · 1992

Recent decisions in FOZ

The FOZ category page

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  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K912563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912563: Angel Wing Safety Blood Collection and Infusion SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912563

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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