510(k) Report

510(k) · Cleared

Cleared

Noxilizer Surgical Ruler

K160501510(k) TraditionalCleared May 26, 201693-day reviewClass I21 CFR 878.4800

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

Noxilizer, Inc. · FTY Tape, Measuring, Rulers And Calipers

Cleared on May 26, 2016 as substantially equivalent to K790660 (Richard-Allan Medical Ind., Inc., 1979) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 1979.

Decided
May 26, 2016
Review
93 days
Class
Class I
Product code
FTY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K790084 (1979). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1979: 1 other ancestorK790084 · Surgical Ruler and Pen · Devon Industries, Inc. · 19791980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor K790084 · Surgical Ruler and Pen · Devon Industries, Inc. · 19790
  1. Root · 1 generation backK790084 Surgical Ruler and PenDevon Industries, Inc. · 1979
  2. This deviceK160501 Noxilizer Surgical RulerNoxilizer, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790084Surgical Ruler and PenDevon Industries, Inc.1979—
0 (this device)K160501Noxilizer Surgical RulerNoxilizer, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
FIG. 1 — Lineage of K160501, 1979–2016Source: 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 FTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K790660Surgical Ruler
Summary page 4
…cal instrument for general use (21 CFR 878.4800) Regulatory Classification: Class I Product Code: FTY Predicate Devices Richard Allan Surgical Ruler (K790660) Devon Surgical Ruler (K790084) Device Description The Noxilizer Surgical Ruler is a 6” x ½” stainless steel surgi…
Richard-Allan Medical Ind., Inc.1979—
*K790084Surgical Ruler and Pen
Summary page 4
…878.4800) Regulatory Classification: Class I Product Code: FTY Predicate Devices Richard Allan Surgical Ruler (K790660) Devon Surgical Ruler (K790084) Device Description The Noxilizer Surgical Ruler is a 6” x ½” stainless steel surgical ruler with laser engraved m…
Devon Industries, Inc.1979—

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 FTY devices

FTY Tape, Measuring, Rulers And Calipers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · FTY

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTY

Too few FTY 510(k)s in any year since 2007 to give a median.

Recalls per year · FTY

4in 2010

2010: 4
2007high 4 (2010) · low 0 (2007)2026

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

Adverse event reports per year · FTY

9in 2025

2009: 22011: 22012: 12013: 32014: 22015: 32017: 52018: 22019: 112020: 1122021: 1612022: 932023: 92024: 122025: 9
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code FTY, 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
20070—00
20080—00
20090—02
20100—40
20110—02
20120—01
20130—03
20140—02
20150—03
20161—00
20170—05
20180—02
20190—011
20200—0112
20210—0161
20220—093
20230—09
20240—012
20250—09
20260—0—

What is it indicated for?

The Noxilizer Surgical Ruler is a sterile, single use, manual measurement device intended to be used in various general surgical procedures.

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

Recent decisions in FTY

The FTY category page

  • K951064Disposable Wound Measure Guide, Plastic, Protector, Wound, PlasticS-E Sales & Distribution, Inc. · 1995
  • K934930Olympic Auto-LengthOlympic Medical Corp. · 1993
  • K932112Olympic Infa-LengthOlympic Medical Corp. · 1993
  • K883485Stryker Pressure Monitor SystemStryker Corp. · 1988
  • K880441Pediatric Airway Measurement System & P.a.M.S.Plane Iii, Inc. · 1988

https://510kreport.com/device/K160501 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160501: Noxilizer Surgical Ruler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160501

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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