510(k) Report

510(k) · Cleared

Cleared

Imbibe II Syringe

K030208510(k) TraditionalCleared Apr 16, 200385-day reviewClass II21 CFR 880.5860

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

Orthovita, Inc. · FMF Syringe, Piston

Cleared on Apr 16, 2003 after an 85-day review. The FDA summary names its predicate without a number. 121 later devices descend from it.

Decided
Apr 16, 2003
Review
85 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

121 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2007: 1 descendant cleared2005: 4 descendants cleared2003: 1 descendant cleared2006: 4 descendants cleared2004: 1 descendant cleared2012: 3 descendants cleared2014: 13 descendants cleared2010: 5 descendants cleared2015: 9 descendants cleared2013: 4 descendants cleared2009: 2 descendants cleared2019: 6 descendants cleared2021: 6 descendants cleared2024: 11 descendants cleared2011: 6 descendants cleared2016: 5 descendants cleared2022: 4 descendants cleared2017: 4 descendants cleared2018: 7 descendants cleared2025: 4 descendants cleared2026: 3 descendants cleared2023: 8 descendants cleared2020: 8 descendants cleared200020052010201520202025
  1. This deviceK030208 Imbibe II SyringeOrthovita, Inc. · 2003
  2. Descendant · cites it directly · 73 of its ownK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
  3. Descendant · 2 generations on · 51 of its ownK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  4. Descendant · cites it directly · 50 of its ownK032130 Vitoss-Filled CartridgeOrthovita, Inc. · 2003
  5. Descendant · 2 generations on · 47 of its ownK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
  6. Descendant · cites it directly · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 42006: 42007: 12008: 22009: 22010: 52011: 62012: 32013: 42014: 132015: 92016: 52017: 42018: 72019: 62020: 82021: 62022: 42023: 82024: 112025: 42026: 3
2003high 13 (2014) · low 1 (2003)2026

Most influential descendants

Showing 5 of 121 · See all
  • K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004 · cites it directly73descendants
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · 2 generations on51descendants
  • K032130Vitoss-Filled CartridgeOrthovita, Inc. · 2003 · cites it directly50descendants
  • K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc. · 2008 · 2 generations on47descendants
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · cites it directly47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030208Imbibe II SyringeOrthovita, Inc.2003—
+1K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.2004—
+2K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
+1K032130Vitoss-Filled CartridgeOrthovita, Inc.2003—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &…Orthovita, Inc.2008—
+1K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200540
200640
200710
200820
200920
201050
201160
201230
201340
2014130
201590
201650
201740
201870
201960
202080
202160
202240
202380
2024110
202540
202630
FIG. 1 — Lineage of K030208, 2003–2026Source: 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), 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 FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Piston Syringe
Named without a submission number
—

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.200473
K032130Vitoss-Filled CartridgeOrthovita, Inc.200350
K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.200747
K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637
K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061
K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080
K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc.20050

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, K041991 (Isotis Orthobiologics, Inc., 2004) has gone furthest, with 73 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The IMBIBE I1 Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon’s choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Indications for use as stated in the FDA summary.

More from Orthovita, Inc.

23 FDA decisions under this applicant name. See the company

  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
  • K161447HydroSet XTOrthovita, Inc. · 20162 recalls
  • K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
  • K153306Imbibe NeedleOrthovita, Inc. · 2015
  • K140868Stryker Kwic NeedleOrthovita, Inc. · 2014

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K030208 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030208: Imbibe II Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030208

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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