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

CCM — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

110 daysmedian FDA review time

278 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K081823	MASTERSCREEN PAED - BABY BODY	Viasys Healthcare GmbH	2009-05-18	325
K023796	MS PAED-BABY BODY	Erich Jaeger GmbH	2003-03-03	110
K943259	1085 ULTIMATE E PLETHYSMOGRAPH	Medical Graphics Corp.	1995-04-10	278
K893420	MASTERLAB PFT AND MASTERLAB BODY BOX	Quinton, Inc.	1989-06-23	57
K853390	INFANT BODY TEST	Erich Jaeger, Inc.	1986-02-05	176
K852102	COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM	Warren E. Collins, Inc.	1985-07-31	77
K852088	SYSTEM 1085 BODY PLETHYSMOGRAPH	Medical Graphics Corp.	1985-07-30	78
K843846	UNIVERSAL-BODYTEST	Erich Jaeger, Inc.	1985-02-14	136
K843851	BODYSCREEN II	Erich Jaeger, Inc.	1985-02-14	136
K791705	4200 PNEUMATIC MOUTH SHUTTER	Hans Rudolph, Inc.	1979-10-04	37
K772367	CHEST BELLOWS, SMALL	Honeywell, Inc.	1978-01-11	15

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