510(k) Report

510(k) · Cleared

Cleared

Simon Nitinol Filter/Straight Line System

K963014510(k) TraditionalCleared Nov 18, 1996108-day reviewClass II21 CFR 870.3375

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

Nitinol Medical Technologies, Inc. · DTK Filter, Intravascular, Cardiovascular

Cleared on Nov 18, 1996 as substantially equivalent to K944353 (Nitinol Medical Technologies, Inc., 1995) and 3 other predicates after a 108-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided
Nov 18, 1996
Review
108 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K894703 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1997: 1 descendant clearedK894703 · Simon Nitinol Filter · Nitinol Medical Technologies, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K894703 · Simon Nitinol Filter · Nitinol Medical Technologies, Inc. · 19900
  1. Root · 1 generation backK894703 Simon Nitinol FilterNitinol Medical Technologies, Inc. · 1990
  2. This deviceK963014 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK970099 Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970099Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894703Simon Nitinol FilterNitinol Medical Technologies, Inc.1990—
0 (this device)K963014Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc.1996—
+1K970099Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K963014, 1990–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DTK? 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 DTK device

  1. #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 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? (4)

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
*K944353Simon Nitinol Filter
Summary page 2
…Vena Cava Filter System Product Code DTK Page 1 \\\DC - 57841/1 - 0305594.01 K636/ Predicate Devices 1. Simon Nitinol Filter/Straight Line™ System (K944353) 2. Simon Nitinol Filter™ System (K940489, K912144, and K894703) Intended Use The intended use of Nitinol Medical Technologies,…
Nitinol Medical Technologies, Inc.1995—
*K940489Simon Nitinol Filter
Summary page 2
…Page 1 \\\DC - 57841/1 - 0305594.01 K636/ Predicate Devices 1. Simon Nitinol Filter/Straight Line™ System (K944353) 2. Simon Nitinol Filter™ System (K940489, K912144, and K894703) Intended Use The intended use of Nitinol Medical Technologies, Inc.’s (“NMT”) Simon Nitinol Filter/Straig…
Nitinol Medical Technologies, Inc.1994—
*K912144Simon Nitinol Filter, Modification
Summary page 2
…\\\DC - 57841/1 - 0305594.01 K636/ Predicate Devices 1. Simon Nitinol Filter/Straight Line™ System (K944353) 2. Simon Nitinol Filter™ System (K940489, K912144, and K894703) Intended Use The intended use of Nitinol Medical Technologies, Inc.’s (“NMT”) Simon Nitinol Filter/Straight Line™…
Nitinol Medical Technologies, Inc.1991—
*K894703Simon Nitinol Filter
Summary page 2
…1/1 - 0305594.01 K636/ Predicate Devices 1. Simon Nitinol Filter/Straight Line™ System (K944353) 2. Simon Nitinol Filter™ System (K940489, K912144, and K894703) Intended Use The intended use of Nitinol Medical Technologies, Inc.’s (“NMT”) Simon Nitinol Filter/Straight Line™ System (“SNF/…
Nitinol Medical Technologies, Inc.1990—

Also cleared against K944353: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970099Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc.19970

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 4 ancestors has a recall.
  • Of its descendants, K970099 (Nitinol Medical Technologies, Inc., 1997) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K944353.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTK

5in 2024

2007: 32008: 62009: 32010: 32011: 22012: 52013: 32014: 22015: 22016: 32017: 52018: 22021: 22024: 5
2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007: 87 days median2008: 87 days median2009: 380 days median2010: 50 days median2012: 156 days median2013: 91 days median2016: 84 days median2017: 88 days median2024: 29 days median
2007high 380 (2009) · low 29 (2024)2026

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

Recalls per year · DTK

1in 2025

2007: 12013: 12015: 12016: 22019: 62022: 22025: 1
2007high 6 (2019) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTK

432in 2025

2007: 3642008: 3452009: 4562010: 3692011: 4392012: 3512013: 4732014: 4512015: 8592016: 2,5742017: 4,3642018: 3,9382019: 6,4672020: 5,4052021: 5,3572022: 2,1912023: 5832024: 4062025: 432
2007high 6,467 (2019) · low 345 (2008)2025

MAUDE reports naming product code DTK, 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
20073871364
20086870345
200933800456
20103500369
20112—0439
201251560351
20133911473
20142—0451
20152—1859
201638422,574
201758804,364
20182—03,938
20190—66,467
20200—05,405
20212—05,357
20220—22,191
20230—0583
20245290406
20250—1432
20260—0—

What is it indicated for?

The intended use of Nitinol Medical Technologies, Inc.’s (“NMT”) Simon Nitinol Filter/Straight Line™ System (“SNF/SL System”) is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K944353

1 other device cites the same predicate.

  • K963016Simon Nitinol Filter SystemNitinol Medical Technologies, Inc. · 1996

More from Nitinol Medical Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K970099Simon Nitinol Filter/Straight Line SystemNitinol Medical Technologies, Inc. · 1997
  • K963016Simon Nitinol Filter SystemNitinol Medical Technologies, Inc. · 1996
  • K944353Simon Nitinol FilterNitinol Medical Technologies, Inc. · 1995
  • K940489Simon Nitinol FilterNitinol Medical Technologies, Inc. · 1994
  • K912144Simon Nitinol Filter, ModificationNitinol Medical Technologies, Inc. · 1991

Recent decisions in DTK

The DTK category page

  • K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
  • K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. · 2024
  • K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L. · 2024
  • K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd · 2024
  • K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum…William Cook Europe Aps · 2024

https://510kreport.com/device/K963014 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963014: Simon Nitinol Filter/Straight Line System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963014

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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