510(k) Report

510(k) · Cleared

Cleared

Empty Sterile Carpuject

K820164510(k) TraditionalCleared Feb 24, 198235-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

Sterling Drug, Inc. · FMF Syringe, Piston

Cleared on Feb 24, 1982 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Feb 24, 1982
Review
35 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2004: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2018: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared19801990200020102020
  1. This deviceK820164 Empty Sterile CarpujectSterling Drug, Inc. · 1982
  2. Descendant · cites it directly · 5 of its ownK063180 Isecure Syringe Cartridge HolderHospira, Inc. · 2006
  3. Descendant · 2 generations on · 2 of its ownK180345 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2018
  4. Descendant · 3 generations on · 1 of its ownK190987 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2019
  5. Descendant · cites it directly · 1 of its ownK083583 Xpresse Injection SystemNordson Efd · 2009
  6. Descendant · 4 generations on · 0 of its ownK203321 Cystoject Syringe LeverUrogen Pharma, Ltd. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12008: 12009: 12013: 12018: 12019: 12020: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all
  • K063180Isecure Syringe Cartridge HolderHospira, Inc. · 2006 · cites it directly5descendants
  • K180345Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2018 · 2 generations on2descendants
  • K190987Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2019 · 3 generations on1descendant
  • K083583Xpresse Injection SystemNordson Efd · 2009 · cites it directly1descendant
  • K203321Cystoject Syringe LeverUrogen Pharma, Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820164Empty Sterile CarpujectSterling Drug, Inc.1982—
+1K063180Isecure Syringe Cartridge HolderHospira, Inc.2006—
+2K180345Uroject12 Syringe LeverUrogen Pharma, Ltd.2018—
+3K190987Uroject12 Syringe LeverUrogen Pharma, Ltd.2019—
+1K083583Xpresse Injection SystemNordson Efd2009—
+4K203321Cystoject Syringe LeverUrogen Pharma, Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200810
200910
201310
201810
201910
202010
FIG. 1 — Lineage of K820164, 1982–2020Source: 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 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K063180Isecure Syringe Cartridge HolderHospira, Inc.20065
K083583Xpresse Injection SystemNordson Efd20091
K081241Weigao Empty Cartridge SyringeShandong Weigao Group Medical Polymer Co., Ltd.20080
K042314Syringe Grip for the Avonex Pre-Filled SyringeBiogen20040

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, K063180 (Hospira, Inc., 2006) has gone furthest, with 5 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)—

More from Sterling Drug, Inc.

9 FDA decisions under this applicant name. See the company

  • K901369Green Label Biobrane II and Red Label Biobrane IISterling Drug, Inc. · 1990
  • K896110Biobrane (R) IISterling Drug, Inc. · 1989
  • K875275Winthrop Pharmaceuticals Contrast Media WarmerSterling Drug, Inc. · 1988
  • K840260Periograf Durapatite 40-60 MeshSterling Drug, Inc. · 1984
  • K820023Conagraf TM Durapatite ConesSterling Drug, Inc. · 1982

Recent decisions in FMF

The FMF category page

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  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
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  • 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/K820164 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820164: Empty Sterile Carpuject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820164

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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