510(k) · Cleared

Cleared

Navigator I

K032879510(k) TraditionalCleared Nov 13, 200359-day reviewClass II21 CFR 890.3800

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

Adaptive Healthcare Technologies, Inc. · INI Vehicle, Motorized 3-Wheeled

Cleared on Nov 13, 2003 as substantially equivalent to K880425 (A-Bec Mobility, Inc., 1988) and 7 other predicates after a 59-day review. Its family tree reaches back 2 generations to 1994.

Decided: Nov 13, 2003
Review: 59 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K926295 (1994). 9 ancestors in all, the oldest K830345 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926295 Legend SC 300Pride Health Care, Inc. · 1994
1 generation backK971043 Golden EagleGolden Technologies, Inc. · 1997
This deviceK032879 Navigator IAdaptive Healthcare Technologies, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926295	Legend SC 300	Pride Health Care, Inc.	1994	—
−1	K971043	Golden Eagle	Golden Technologies, Inc.	1997	—
0 (this device)	K032879	Navigator I	Adaptive Healthcare Technologies, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0
1988	1	0
1994	2	0
1996	2	0

FIG. 1 — Lineage of K032879, 1994–2003Source: 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 INI? 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 INI device

#1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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? (8)

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
*	K880425	Sterling (Motorized Vehicle) Summary page 1 …tion Name: Motorized Three-wheeled Vehicle Identification of predicate devices - Primary Predicate Device - A-BEC Mobility, Inc. Sterling Scooter fK880425), Product Code IN1 SPECIFIC FEATURE Secondary Predicate Devices RELATED TO SPECIFIC FEATURE…	A-Bec Mobility, Inc.	1988	—
*	K924515	Electric Mobility Rascal	Electric Mobility Corp.	1994	6
*	K830345	Scooter, Vehicle Motorized Summary page 1 …er) Electric Mobility C o p Rascal Convertible (K9245 IS). Product Code IN1 Parking Brakes Amigo Sales Inc., Scooter, Motorized (K830345), Product Code IN1 Anti-tit, Wheels Varv Width Amigo Sales Inc.. Scooter. Motorized (K830345). Product Code IN1…	Amigo Sales, Inc.	1983	—
*	K935410	Hoveround MPV Summary page 1 …-tit, Wheels Varv Width Amigo Sales Inc.. Scooter. Motorized (K830345). Product Code IN1 Rear Motor Drive System Hoveround Corp. Hoveround MFV (K935410), Product Code IT1 Torsional Elements - Everest & Jennings Inc., Modular Power Base (K85405 l), Product…	Hoveround Corp.	1994	—
*	K854051	Modular Power Base	Everest & Jennings, Inc.	1985	—
*	K945936	JAZZY Summary page 1 …ements - Everest & Jennings Inc., Modular Power Base (K85405 l), Product Code IT1 Rotational Feature and Front Pride Health Care Inc.. JAZZY (K945936), Product Code IT1 and Rear Springs Golden Technologies Inc.. Golden Eagle GT2000 (K97 1043). Produc…	Pride Health Care, Inc.	1996	1
*	K971043	Golden Eagle Summary page 1 …ature and Front Pride Health Care Inc.. JAZZY (K945936), Product Code IT1 and Rear Springs Golden Technologies Inc.. Golden Eagle GT2000 (K97 1043). Product Code IN1 Rear Caster Wheel Damper TEFTEC Corp, OMEGATRAC (K9SS210). Product Code IT1…	Golden Technologies, Inc.	1997	—
*	K955240	Omegatrac by Teftec Our reading of the summary gave K955210, FDA’s number for Sas Salmonella H F,G, Antiserum (Sa Scientific, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TEFTEC Corp. OMEGATRAC”.	Teftec Corp.	1996	—

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 9 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
2 of the 9 ancestors have a recall of any class.

How does its category compare?

All INI devices

INI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · INI

21so far in 2026, the most since 2007

2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007high 575 (2021) · low 28 (2008)2026

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

Recalls per year · INI

1in 2013

2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · INI

26in 2025

2007high 567 (2014) · low 25 (2009)2025

MAUDE reports naming product code INI, 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	18	29	2	64
2008	7	28	0	29
2009	12	41	0	25
2010	5	46	3	56
2011	5	130	3	70
2012	1	—	0	172
2013	2	—	1	454
2014	1	—	0	567
2015	9	202	0	151
2016	1	—	0	76
2017	5	191	0	45
2018	3	266	0	51
2019	4	298	0	25
2020	1	—	0	26
2021	5	575	0	41
2022	6	159	0	41
2023	9	123	0	32
2024	8	137	0	31
2025	15	111	0	26
2026	21	108	0	—

What is it indicated for?

To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032879 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032879: Navigator I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032879

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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