510(k) · Cleared

Cleared

Tenderfoot

K223352510(k) SpecialCleared Mar 2, 2023120-day reviewClass II21 CFR 878.4850

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

Accriva Diagnostics, Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cleared on Mar 2, 2023 as substantially equivalent to K883968 (International Technidyne Corp., 1988) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 2, 2023
Review: 120 days
Class: Class II
Product code: FMK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K883968 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK883968 TenderfootInternational Technidyne Corp. · 1988
This deviceK223352 TenderfootAccriva Diagnostics, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883968	Tenderfoot	International Technidyne Corp.	1988	—
0 (this device)	K223352	Tenderfoot	Accriva Diagnostics, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K223352, 1988–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FMK? 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 FMK device

#1 K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII…score 25.0 · 3 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K883968	Tenderfoot Summary page 4 …Class II Product Code: FMK Review Panel: General and Plastic Surgery (79) III. PREDICATE DEVICE Primary Predicate: Tenderfoot (K883968), Product Code: FMK Additional Predicate: Tenderfoot (K911997), Product Code: FMK IV. DEVICE DESCRIPTION Tenderfoot is…	International Technidyne Corp.	1988	—
*	K911997	Tenderfoot (R), Modification Summary page 4 …General and Plastic Surgery (79) III. PREDICATE DEVICE Primary Predicate: Tenderfoot (K883968), Product Code: FMK Additional Predicate: Tenderfoot (K911997), Product Code: FMK IV. DEVICE DESCRIPTION Tenderfoot is an automated skin incision device used to collect capillary blood f…	International Technidyne Corp.	1991	—

Also cleared against K883968: 2 other devices →

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.
2 other devices also cite its predicate K883968.

How does its category compare?

All FMK devices

FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FMK

4in 2025

2007high 25 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMK

59in 2025

2007high 95 (2023) · low 57 (2024)2026

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

Recalls per year · FMK

1in 2009

2007high 4 (2007) · low 0 (2010)2026

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

Adverse event reports per year · FMK

47in 2025

2007high 1,573 (2012) · low 47 (2025)2025

MAUDE reports naming product code FMK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	4	1,206
2008	0	—	2	1,100
2009	0	—	1	882
2010	2	—	0	910
2011	0	—	0	1,493
2012	2	—	0	1,573
2013	1	—	0	1,301
2014	0	—	0	890
2015	0	—	0	781
2016	1	—	0	539
2017	1	—	0	531
2018	0	—	0	534
2019	2	—	0	399
2020	0	—	0	313
2021	1	—	0	245
2022	25	87	0	254
2023	10	95	0	282
2024	10	57	0	243
2025	4	59	0	47
2026	5	68	0	—

What is it indicated for?

Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers.

For medical device use. For healthcare professional use, prescription only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223352 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223352: Tenderfoot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223352

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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