510(k) · Cleared

Cleared

Ora-50 Electrothermal System and Accessories

K994333510(k) SpecialCleared Jan 18, 200026-day reviewClass II21 CFR 878.4400

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

Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 18, 2000 as substantially equivalent to K964071 (Oratec Interventions, Inc., 1996) after a 26-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jan 18, 2000
Review: 26 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964071 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK964071 Oratec Interventions Model Ora 50 Electrothermal GeneratorOratec Interventions, Inc. · 1996
This deviceK994333 Ora-50 Electrothermal System and AccessoriesOratec Interventions, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964071	Oratec Interventions Model Ora 50 Electrothermal Generator	Oratec Interventions, Inc.	1996	—
0 (this device)	K994333	Ora-50 Electrothermal System and Accessories	Oratec Interventions, Inc.	2000	—

FIG. 1 — Lineage of K994333, 1996–2000Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (1)

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
*	K964071	Oratec Interventions Model Ora 50 Electrothermal Generator Summary page 1 …name Electrosurgical generator and accessories Proprietary name ORA-50 ElectroThermal System and Accessories C. Predicate Device: Model ORA-50 ElectroThermal Generator, K964071 D. Device Description: The ORATEC Interventions ORA-50 ElectroThermal System (“ORA-50”) is a single channel, 50-watt, electroth…	Oratec Interventions, Inc.	1996	—

Also cleared against K964071: 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?

Its one ancestor has no recall.
2 other devices also cite its predicate K964071.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The ORA-50 ElectroThermal System (“ORA-50”) and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical generators.

Contraindications for Use: The ORA-50 ElectroThermal System and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interests of the patient.

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

https://510kreport.com/device/K994333 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994333: Ora-50 Electrothermal System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994333

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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