Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Theratronics, Inc. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

191 daysmedian FDA review time

740 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983917	THERATRON ELITE	Theratronics, Inc.	1998-12-04	30	2
K970236	THERAPLAN PLUS VERSION 1.2	Theratronics, Inc.	1997-07-09	169	0
K964606	THERATRON 780E	Theratronics, Inc.	1997-06-26	220	1
K964607	THERATON 1000E	Theratronics, Inc.	1997-05-28	191	1
K954679	THERAPLAN PLUS	Theratronics, Inc.	1996-11-08	395	0
K940237	THERAPLAN V05B/ TP-11 V09B	Theratronics, Inc.	1994-07-26	189	0
K922276	THERAC 25	Theratronics, Inc.	1994-05-25	740	0
K894165	THERATRON 1000	Theratronics, Inc.	1990-02-01	230	0
K820782	THERATRONIC STIMULATOR	Theratronics, Inc.	1982-06-03	72	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda