510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Gripper Plus Needle

K021999510(k) TraditionalCleared Aug 13, 200255-day reviewClass II21 CFR 880.5440Recalls 1

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

Deltec, Inc. · FPA Set, Administration, Intravascular

Cleared on Aug 13, 2002 after a 55-day review. The FDA summary names its predicate without a number. 21 later devices descend from it. It has been recalled once.

Decided
Aug 13, 2002
Review
55 days
Class
Class II
Product code
FPA
Recalls
1
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2012: 1 descendant cleared2010: 1 descendant cleared2011: 2 descendants cleared2008: 1 descendant cleared2016: 1 descendant cleared2009: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2020: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK021999 Gripper Plus NeedleDeltec, Inc. · 2002
  2. Descendant · cites it directly · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
  3. Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  5. Descendant · 4 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
  6. Descendant · 4 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2007: 22008: 12009: 12010: 12011: 22012: 12014: 12016: 12017: 22020: 12021: 32023: 12024: 12025: 22026: 1
2007high 3 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 21 · See all
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · cites it directly18descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
  • K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 4 generations on2descendants
  • K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021999Gripper Plus NeedleDeltec, Inc.2002—
+1K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+3K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+4K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023—
+4K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200910
201010
201120
201210
201410
201610
201720
202010
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K021999, 2002–2026Source: 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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (2)

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
*—GRIPPER Needle
Named without a submission number
—
*—Huber Plus Safety Infusion Set
Named without a submission number
—

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718
K063631Polyperf / Polyperf SafeLaboratoires Perouse20071

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 15, 2019Class IIZ-0253-2020Nonconforming Material/ComponentSupplier initiated recall of the GRIPPER Needles

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070116 (Smiths Medical MD, Inc., 2007) has gone furthest, with 18 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The GRIPPERPLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

Indications for use as stated in the FDA summary.

More from Deltec, Inc.

5 FDA decisions under this applicant name. See the company

  • K031361Cadd High-Volume Administration Sets with FlowstopDeltec, Inc. · 20031 Class I recall
  • K030983Truflow Dual-Lumen Polyurethane Long-Term Straight Dialysis Catheter (12.5 FR X 24 CM) with Tray, Truflow…Deltec, Inc. · 2003
  • K022221Truflow Long-Term and Short-Term Dual-Lumen Dialysis CathetersDeltec, Inc. · 2003
  • K020655Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc. · 20026 recalls

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K021999 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021999: Gripper Plus Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021999

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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