510(k) · Cleared

Cleared

Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002

K081264510(k) TraditionalCleared Feb 13, 2009284-day reviewClass I21 CFR 880.6760

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

Children'S Health First, Inc. · FMQ Restraint, Protective

Cleared on Feb 13, 2009 as substantially equivalent to K031096 (International Biomedics, Inc., 2003) and 3 other predicates after a 284-day review. Its family tree reaches back 2 generations to 1985.

Decided: Feb 13, 2009
Review: 284 days
Class: Class I
Product code: FMQ
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K850496 (1985). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK850496 Transport Incubator 185Airborne Life Support Systems, Inc. · 1985
1 generation backK031096 Modification to Transport Incubator 185International Biomedics, Inc. · 2003
This deviceK081264 Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K850496	Transport Incubator 185	Airborne Life Support Systems, Inc.	1985	—
−1	K031096	Modification to Transport Incubator 185	International Biomedics, Inc.	2003	—
0 (this device)	K081264	Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002	Children'S Health First, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2000	1	0

FIG. 1 — Lineage of K081264, 1985–2009Source: 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 FMQ? 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K031096	Modification to Transport Incubator 185 Summary page 1 …mon name: Neonatal Incubator restraint strap Classification name: Neonatal Transport Incubator (accessory);(21CFR880.5410), Product code: FPL) Substantial Equivalence: K031096/K850496A Model 185 with restraint straps International Bio Medical 880.5410…	International Biomedics, Inc.	2003	—
*	K850496	Transport Incubator 185 Summary page 1 …: Neonatal Incubator restraint strap Classification name: Neonatal Transport Incubator (accessory);(21CFR880.5410), Product code: FPL) Substantial Equivalence: K031096/K850496A Model 185 with restraint straps International Bio Medical 880.5410…	Airborne Life Support Systems, Inc.	1985	—
*	K001019	TI500 Globe-Trotter Transport System Our reading of the summary gave K000019, FDA’s number for Single Size Tendon Spacer (Medist International). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Model T1500 & Ti500 with restraint straps — Hill-Rom Airshield”.	Hill-Rom Air-Shields	2000	2
*	K941106	Model TI500 Isolette Infant Incubator Summary page 1 …io Medical 880.5410 Airborne Life Support Part #216-0350 Restraint Straps KOO0 01 9/K941106 Model T1500 & Ti50O with HilI-ROM Airshield restraint straps / 880.5410…	Air-Shields, Inc.	1994	1

Also cleared against K031096: 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?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
2 of the 4 ancestors have a recall of any class.
2 other devices also cite its predicate K031096.

How does its category compare?

All FMQ devices

FMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FMQ

1in 2011

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMQ

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

Recalls per year · FMQ

1in 2021

2007high 22 (2009) · low 0 (2007)2026

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

Adverse event reports per year · FMQ

14in 2025

2007high 71 (2012) · low 10 (2008)2025

MAUDE reports naming product code FMQ, 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	—	0	16
2008	1	—	2	10
2009	1	—	22	42
2010	0	—	0	20
2011	1	—	0	31
2012	0	—	1	71
2013	0	—	0	31
2014	0	—	2	43
2015	0	—	0	33
2016	0	—	0	24
2017	0	—	0	54
2018	0	—	0	23
2019	0	—	1	57
2020	0	—	0	38
2021	0	—	1	33
2022	0	—	0	54
2023	0	—	0	47
2024	0	—	0	58
2025	0	—	0	14
2026	0	—	0	—

What is it indicated for?

Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081264 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081264: Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081264

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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