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

Birtcher Corp. — Predicate Candidate Screening

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

41 daysmedian FDA review time

97 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K881328	MODEL 375 ECG	Birtcher Corp.	1988-05-18	50	0
K860718	ELECTROSURGERY PENCIL, MODEL 767	Birtcher Corp.	1986-03-24	26	0
K860687	BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768	Birtcher Corp.	1986-03-24	27	0
K854814	SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33	Birtcher Corp.	1986-01-13	41	0
K854864	BI-POLAR FORCEPS	Birtcher Corp.	1985-12-24	19	0
K850668	ELECTROSURGICAL UNIT 774	Birtcher Corp.	1985-05-20	89	0
K850943	MODEL 775 BIPOLAR COAGULATOR	Birtcher Corp.	1985-05-20	74	0
K844101	CARDIO-NEC MODEL 365	Birtcher Corp.	1985-04-09	168	0
K844104	CARDIO ANALYZER MODEL 380	Birtcher Corp.	1985-03-06	134	0
K850297	ELECTROSURGICAL PENCIL HOLDER 720	Birtcher Corp.	1985-02-28	35	0
K844103	CARDIOPAC DEFIBRILLATOR 444	Birtcher Corp.	1985-01-18	87	0
K843221	MEGASON MODEL 150	Birtcher Corp.	1984-08-24	8	0
K823491	BIRT-A-SWITCH DSP #712	Birtcher Corp.	1983-01-07	45	0
K823488	ELECTROCARDIOGRAPH #334	Birtcher Corp.	1982-12-30	37	0
K823492	BIRT-A-PAD #730	Birtcher Corp.	1982-12-09	16	0
K821888	AUTOMATIC SINGLE CHANNEL ECG #399	Birtcher Corp.	1982-07-30	35	0
K821491	35MM ANGIOGRAM VIEWER ANALYZER	Birtcher Corp.	1982-07-08	51	0
K821157	HETERODYNAMIC	Birtcher Corp.	1982-06-23	62	0
K821453	CARDIOCASSETTE II #363	Birtcher Corp.	1982-05-25	11	0
K800617	HYFRECATOR, #733	Birtcher Corp.	1980-05-02	45	4
K800632	MODEL 118 PULSE MEGASON	Birtcher Corp.	1980-05-02	43	0
K781949	ELECTROSURGERY MODEL 771	Birtcher Corp.	1979-02-26	97	0
K780755	SHORTWAVE DIATHERMY MODEL 802	Birtcher Corp.	1978-05-12	4	0
K761023	SIMULATOR, 10 LEAD ECG	Birtcher Corp.	1977-01-31	81	0
K761231	MODEL 738 BIRT-A-PAD	Birtcher Corp.	1977-01-14	35	0
K770037	ELECTROCARDIOGRAPH MODEL 344	Birtcher Corp.	1977-01-14	4	0
K760722	BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE	Birtcher Corp.	1976-11-01	35	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