510(k) Report

510(k) · Cleared

Cleared

Sure-Lok

K021315510(k) AbbreviatedCleared Aug 21, 2002118-day reviewClass II21 CFR 880.5570

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

Vital Signs, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Aug 21, 2002 as substantially equivalent to K950098 (Hammer-Plane, Inc., 1995) and 1 other predicate after a 118-day review. Its family tree reaches back 1 generation to 1995.

Decided
Aug 21, 2002
Review
118 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K946289 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK946289 · Devons Point Lok Needle Protection Device · Devon Industries, Inc. · 199519961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K946289 · Devons Point Lok Needle Protection Device · Devon Industries, Inc. · 19950
  1. Root · 1 generation backK946289 Devons Point Lok Needle Protection DeviceDevon Industries, Inc. · 1995
  2. This deviceK021315 Sure-LokVital Signs, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946289Devons Point Lok Needle Protection DeviceDevon Industries, Inc.1995—
0 (this device)K021315Sure-LokVital Signs, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K021315, 1995–2002Source: 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 FMI? 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 FMI device

  1. #1 K252886 Pen Needlescore 14.5 · 4 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? (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
*K950098Needle Safety Cover
Summary page 1
…hed under Section 514 of thr: Food, Drug and Cosmetic Act for this device. Predicate Device The predicate devices are the NeeclleTrap mf 1'530(k)K950098J and thc Information Point-Lok [5IO@) K9462891. Intended Use The Sure-LokTM secondary needle kit contains a ne…
Hammer-Plane, Inc.1995—
*K946289Devons Point Lok Needle Protection Device
Summary page 1
…Drug and Cosmetic Act for this device. Predicate Device The predicate devices are the NeeclleTrap mf 1'530(k)K950098J and thc Information Point-Lok [5IO@) K9462891. Intended Use The Sure-LokTM secondary needle kit contains a needle w/Sure-Lok''M adapter. sheath,…
Devon Industries, Inc.1995—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

What is it indicated for?

The Sure-LokTM secondary needle kit contains a needle w/Sure-LokTM adapter, sheath, and base stand that is intended for use with standard her-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-LokTM adapter engages with the sheath, preventing needle exposure.

Indications for use as stated in the FDA summary.

More from Vital Signs, Inc.

75 FDA decisions under this applicant name. See the company

  • K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012
  • K041309Imask TMVital Signs, Inc. · 2004
  • K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
  • K022402Disposable Pressure ManometerVital Signs, Inc. · 2002
  • K002454Breas HA50 Humidifier, Model HA50Vital Signs, Inc. · 2001

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https://510kreport.com/device/K021315 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021315: Sure-Lok.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021315

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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