510(k) Report

510(k) · Cleared

Cleared

Micromedics Fibrijet Aerosol Applicator

K012868510(k) TraditionalCleared Oct 29, 200163-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

Micromedics, Inc. · FMF Syringe, Piston

Cleared on Oct 29, 2001 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 57 later devices descend from it.

Decided
Oct 29, 2001
Review
63 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

57 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2019: 3 descendants cleared2012: 2 descendants cleared2005: 1 descendant cleared2002: 1 descendant cleared2007: 2 descendants cleared2003: 1 descendant cleared2014: 6 descendants cleared2021: 3 descendants cleared2022: 3 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2016: 3 descendants cleared2025: 3 descendants cleared2011: 2 descendants cleared2024: 5 descendants cleared2017: 2 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK012868 Micromedics Fibrijet Aerosol ApplicatorMicromedics, Inc. · 2001
  2. Descendant · cites it directly · 49 of its ownK021071 PCCS Graft Delivery SystemBiomet, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
  4. Descendant · 3 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  5. Descendant · 4 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  6. Descendant · 5 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 12007: 22010: 12011: 22012: 22014: 62015: 22016: 32017: 22018: 32019: 32020: 72021: 32022: 32023: 62024: 52025: 32026: 1
2002high 7 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 57 · See all
  • K021071PCCS Graft Delivery SystemBiomet, Inc. · 2002 · cites it directly49descendants
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · 2 generations on47descendants
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 3 generations on45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 4 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 5 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012868Micromedics Fibrijet Aerosol ApplicatorMicromedics, Inc.2001—
+1K021071PCCS Graft Delivery SystemBiomet, Inc.20021
+2K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.2007—
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200720
201010
201120
201220
201460
201520
201630
201720
201830
201930
202070
202130
202230
202360
202450
202530
202610
FIG. 1 — Lineage of K012868, 2001–2026Source: 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 510(k) statement (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 16.1 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K021071PCCS Graft Delivery SystemBiomet, Inc.200249
K191659Instylla Delivery KitInstylla, Inc.20193
K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc20051
K122122Regen Spray Applicator,Regen Lab SA20120

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, K021071 (Biomet, Inc., 2002) has gone furthest, with 49 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 Micromedics FibriJet Aerosol Applicator is intended for use

in applying two non-homogeneous fluids to a treatment site.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Micromedics, Inc.

29 FDA decisions under this applicant name. See the company

  • K241739Endoscopic Applicator, 41 cmMicromedics, Inc. · 2024
  • K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
  • K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K120608Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K102563Single Cannula Extended ApplicatorMicromedics, Inc. · 2011

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/K012868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012868: Micromedics Fibrijet Aerosol Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012868

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026